Multi-dose drug delivery device

ABSTRACT

A wearable drug delivery device that can deliver a liquid drug stored in a container to a patient is provided. The container can be a prefilled cartridge that can be loaded into the drug delivery device by the patient or that can be preloaded within the drug delivery device when provided to the patient. A sealed end of the container is pierced to couple the stored liquid drug to a needle conduit that is coupled to a needle insertion component that provides access to the patient. A drive system of the drug delivery device can expel the liquid drug from the cartridge to the patient through the needle conduit. The drive system can be controlled to provide the liquid drug to the patient in a single dose or over multiple doses.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/341,898, filed May 26, 2016, U.S. Provisional Application No.62/374,394, filed Aug. 12, 2016, U.S. Provisional Application No.62/374,881, filed Aug. 14, 2016, U.S. Provisional Application No.62/375,026, filed Aug. 15, 2016, U.S. Provisional Application No.62/385,749, filed Sep. 9, 2016, U.S. Provisional Application No.62/449,845, filed Jan. 24, 2017, and U.S. Provisional Application No.62/449,849, filed Jan. 24, 2017, each of which is incorporated herein byreference in its entirety.

TECHNICAL FIELD

Embodiments generally relate to medication delivery. More particularly,embodiments relate to wearable drug delivery devices.

BACKGROUND

Many conventional drug delivery systems, such as handheldauto-injectors, are designed to rapidly delivery a drug to a patient.These conventional drug delivery systems are generally not suitable fordelivering a drug to a user over relatively longer periods of time asmay be required for many drugs.

As an alternative to conventional auto-injectors, many conventional drugdelivery systems are designed to be wearable and to deliver a drug moreslowly to the patient. However, these conventional wearable drugdelivery systems often require a patient to transfer a drug or othermedicine from a vial to a container within the drug delivery system.Transferring the drug can be a challenging task for many patients as itmay require precise handling of the drug, a transfer mechanism (e.g., asyringe), and the drug delivery system. Some conventional wearable drugdelivery systems use prefilled cartridges that contain the drug intendedfor the patient, obviating the need for such drug transfers. However,these conventional cartridge-based drug delivery systems are often bulkyand cumbersome due to the included cartridge and can be uncomfortablewhen worn by the patient.

A need therefore exists for a more convenient and user-friendly wearabledrug delivery device for providing a drug to a user.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a first exemplary embodiment of a drug deliverydevice.

FIG. 2 illustrates a first exemplary embodiment of various functionalcomponents of the drive delivery device of FIG. 1.

FIG. 3 illustrates a second exemplary embodiment of various functionalcomponents of the drive delivery device of FIG. 1.

FIG. 4 illustrates a top view of the drug delivery device of FIG. 1.

FIG. 5 illustrates a first side view of the drug delivery device of FIG.1.

FIG. 6 illustrates a second side view of the drug delivery device ofFIG. 1.

FIG. 7 illustrates a bottom view of the drug delivery device of FIG. 1.

FIG. 8 illustrates an exemplary method of operation for the drugdelivery device of FIG. 1.

FIG. 9 illustrates a second exemplary embodiment of a drug deliverydevice.

FIG. 10 illustrates a top view of the drug delivery device of FIG. 9.

FIG. 11 illustrates a first side view of the drug delivery device ofFIG. 9.

FIG. 12 illustrates a second side view of the drug delivery device ofFIG. 9.

FIG. 13 illustrates a bottom view of the drug delivery device of FIG. 9.

FIG. 14 illustrates a third exemplary embodiment of a drug deliverydevice.

FIG. 15 illustrates a first exemplary arrangement of internal componentsof the drug delivery devices of FIGS. 1, 9, and 14.

FIG. 16 illustrates a second exemplary arrangement of internalcomponents of the drug delivery devices of FIGS. 1, 9, and 14.

FIG. 17 illustrates an exemplary drive spring release mechanism in afirst state.

FIG. 18 illustrates the exemplary drive spring release mechanism of FIG.17 in a second state.

FIG. 19 illustrates an exemplary mechanism for accessing a liquid drugstored in a drug cartridge.

FIG. 20 illustrates a first exemplary alternative drive system fordelivering a liquid drug to a patient.

FIG. 21 illustrates a second exemplary alternative drive system fordelivering a liquid drug to a patient in a first state of operation.

FIG. 22 illustrates the second exemplary alternative drive system ofFIG. 21 in a second state of operation.

FIG. 23 illustrates the second exemplary alternative drive system ofFIG. 21 in a third state of operation.

FIG. 24 illustrates an exemplary gate control mechanism of the secondexemplary alternative drive system of FIGS. 21, 22, and 23.

FIG. 25 illustrates a fourth exemplary embodiment of a drug deliverydevice.

FIG. 26 illustrates a top view of the drug delivery device of FIG. 25.

FIG. 27 illustrates an activation mechanism of the drug delivery deviceof FIG. 25.

FIG. 28 illustrates a cross-sectional view of a portion of the drugdelivery device shown in FIG. 27.

FIG. 29 illustrates an exemplary implementation of a primary drugcontainer access mechanism.

FIG. 30 illustrates a third exemplary alternative drive system fordelivering a liquid drug to a patient.

FIG. 31 illustrates a fourth exemplary alternative drive system fordelivering a liquid drug to a patient.

FIG. 32 illustrates a fifth exemplary alternative drive system fordelivering a liquid drug to a patient.

FIG. 33 illustrates a sixth exemplary alternative drive system fordelivering a liquid drug to a patient.

FIG. 34 illustrates a seventh exemplary alternative drive system fordelivering a liquid drug to a patient in a first state of operation.

FIG. 35 illustrates the seventh exemplary alternative drive system in asecond state of operation.

FIG. 36 illustrates a fifth exemplary embodiment of a drug deliverydevice.

FIG. 37 illustrates an exemplary embodiment of a needle insertionmechanism.

FIG. 38 illustrates an exemplary track.

FIG. 39 illustrates a first view of an eighth exemplary alternativedrive system for delivering a liquid drug to a patient.

FIG. 40 illustrates a second view of an eighth exemplary alternativedrive system for delivering a liquid drug to a patient.

FIG. 41 illustrates an exemplary embodiment of an alternative routing ofa needle conduit.

DETAILED DESCRIPTION

This disclosure presents various systems, components, and methods fordelivering a liquid drug or medicine to a patient or user. Each of thesystems, components, and methods disclosed herein provides one or moreadvantages over conventional systems, components, and methods.

Various embodiments include a wearable drug delivery device that candeliver a liquid drug stored in a container to a patient or user. Thecontainer can be a prefilled cartridge that can be loaded into the drugdelivery device by the patient or that can be preloaded within the drugdelivery device when provided to the patient. A sealed end of thecontainer can be pierced to couple the stored liquid drug to a needleconduit. The needle conduit can be coupled to a needle insertioncomponent that provides access to the patient. A drive system of thedrug delivery device can expel the liquid drug from the container to thepatient through the needle conduit. The drive system can be controlledto provide the liquid drug to the patient in a single dose or overmultiple doses. The drive system can include an energy storage componentand an energy transfer component to enable the drug delivery device tomaintain a small form factor. As a result, the patient's comfort whenusing the drug delivery device is improved. Other embodiments aredisclosed and described.

FIG. 1 illustrates a first exemplary embodiment of a drug deliverydevice 100. The drug delivery device 100 can include a top portion orcover 102 and a lower portion or base 104. The top portion 102 and thelower portion 104 can together form a housing of the drug deliverydevice 100. The top portion 102 and the lower portion 104 can be coupledtogether to form an outside of the drug delivery device 100. The topportion 102 and the lower portion 104 can be formed from any materialincluding, for example, plastic, metal, rubber, or any combinationthereof.

The drug delivery device 100 can be used to deliver a therapeutic agent(e.g., a drug) drug to a patient or user. In various embodiments, thedrug delivery device 100 can include a container for retaining a liquiddrug. The drug delivery device 100 can be used to deliver the liquiddrug from the container to the patient. Any type of liquid drug can bestored by the drug delivery device 100 and delivered to a patient. Invarious embodiments, the container can contain any therapeutic agentsuch as, for example, a drug, a subcutaneous injectable, a medicine, ora biologic. A patient receiving a drug or other medicine (or any liquid)from the drug delivery device 100 can also be referred to as a user.

The drug delivery device 100 can operate as a bolus drug deliverydevice. In general, the drug delivery device 100 can provide any amountof the stored liquid drug to a patient over any period of time. Invarious embodiments, the drug delivery device 100 can provide the storedliquid drug to the patient in a single dose over a desired amount oftime. In various embodiments, the drug delivery device 100 can providethe stored liquid drug to the patient over multiple doses. Each of themultiple doses can include substantially the same amount of the liquiddrug or the sizes of the doses can vary. Further, each of the multipledoses can be provided to the patient over substantially the same amountof time or the delivery times can vary. Additionally, the times betweenmultiple doses can be approximately equal or can vary.

The drug delivery device 100 can maintain the liquid drug within aprimary drug container. The primary drug container can be a cartridge.As an example, the cartridge can be an International Organization forStandardization (ISO) standardized cartridge. The drug delivery device100 can be provided to the patient with a preloaded and prefilledcartridge. In various embodiments, the drug delivery device 100 caninclude a slot or opening for a patient to load a prefilled cartridgeinto the drug delivery device 100. In various embodiments, the drugdelivery device 100 can be designed and/or intended for a single usesuch that after the liquid drug is delivered to the patient, the drugdelivery device 100 can be discarded. In various embodiments, theprimary drug container can be filled or refilled by a patient such thatthe drug delivery device 100 can be reused. In various embodiments, thedrug delivery device 100 can include a port for accessing and fillingthe primary drug container.

As shown in FIG. 1, the top portion 102 of the drug delivery device 100can include a raised portion 106. The raised portion 106 can beelongated and run along a side of the drug delivery device 100. A liquiddrug cartridge can be approximately positioned under the raised portion106 such that the raised portion 106 accommodates the size andpositioning of the liquid drug container within the drug delivery device102. The top portion 102 can also include a patient interaction elementor component 108. In various embodiments, the patient interactionelement 108 can be a push button or other patient input device. Thepatient interaction element 108 can be used to activate the drugdelivery device 100. For example, when a patient presses on the patientinteraction element 108, the drug delivery device 100 can begindelivering the stored liquid drug to the patient. Prior to activation,the drug delivery device 100 can remain in an idle state of operation.In various embodiments, the patient interaction element 108 can be usedto start, stop, and/or restart delivery of the liquid drug to thepatient to enable a patient to dispense multiple doses of the liquiddrug.

The drug delivery device 100 can be a wearable drug delivery device 100.As a wearable device, the drug delivery device 100 can be an on-bodydelivery system (OBDS). The drug delivery device 100 can be coupled to apatient in a number of ways. For example, the lower portion 104 of thedrug delivery device 100 can include an adhesive for attaching to apatient. In various embodiments, the drug delivery device 100 can beattached to a secondary device attached or worn by the patient such thatthe drug delivery device 100 fits onto or can be coupled to thesecondary device.

FIG. 1 illustrates an exemplary form factor of the drug delivery device100. In various embodiments, the drug delivery device 100 can bedesigned according to any desired form factor—for example, according toany desired shape and size of the top and lower portions 102 and 104.Further, the drug delivery device 100 can include any number ofcomponents that can be coupled together to form the housing of the drugdelivery device 100. In various embodiments, the drug delivery device100 can be a handheld device operating, for example, similar to anauto-injector.

The drug delivery device 100 can also include multiple patientinteraction elements and is not limited to only including the patientinteraction element 108. In various embodiments, the drug deliverydevice 100 can include two or more patient interaction elements 108. Invarious embodiments, the drug delivery device 100 can include an on-bodyinterlock that may be required to be engaged prior to allowing the drugdelivery device 100 to operate. For example, the on-body interlock canbe positioned on a bottom side of the drug delivery device 100 (e.g., onan outside portion of the lower portion 104). The on-body interlock canbe an exposed button or switch that can be passively depressed whencoupled to the patient. After the on-body interlock is depressed, thedrug delivery device 100 can be operated, for example, by a patientinteracting with the patient interaction element 108. In variousembodiments, operation of the drug delivery device 100 can be stoppedwhen the drug delivery device 100 is decoupled or removed from thepatient—for example, when the on-body interlock is no longer passivelydepressed.

In various embodiments, the drug delivery device 100 can operate as amechanical device. For example, the drug delivery device 100 can includeonly mechanical components and/or can provide only mechanicalfunctionality and operation. In various other embodiments, the drugdelivery device 100 can operate as an electromechanical device. Forexample, the drug delivery device 100 can include one or morecontrollers associated memory for controlling various components of thedrug delivery device 100. As an electromechanical device, the drugdelivery device 100 can include other electrical and/orelectromechanical components such as, for example, sensors, userinterfaces, and communication interfaces. In various embodiments, afirst portion of the drug delivery device 100 can be a mechanical basedsystem (e.g., a drive system for expelling a drug from a container fordelivery to the user) while a second portion of the drug delivery device100 can be an electromechanical based system (e.g., components formeasuring and recoding dosage amounts). Operation of the drug deliverydevice 100 can be entirely patient-based, automated, and/orsemi-autonomous.

FIG. 2 illustrates an exemplary embodiment 200 of various functionalcomponents of the drive delivery device 100. FIG. 2 can represent thevarious functional components of the drug delivery device 100 whenimplemented as a mechanical device (e.g., including the function andoperation of the constituent components of the drug delivery device 100depicted in FIG. 2). The functional components depicted in FIG. 2 can becontained or positioned within the drug delivery device 100 (e.g.,contained within the top portion 102 and the lower portion 104).

As shown in FIG. 2, the mechanical implementation of the drug deliverydevice 100 can include a primary drug container 202, a primary drugcontainer access mechanism or component 204, a needle conduit 206, aneedle insertion mechanism or component 208, a drive mechanism orcomponent 210, a user control and/or interaction mechanism or component212, and a patient (or user) adherence or coupling mechanism component214.

The primary drug container 202 can store any type of liquid drug. Asmentioned, the primary drug container 202 can be a cartridge including,for example, an ISO standardized cartridge. The primary drug container202 can be provided as preloaded into the drug delivery device 100 andprefilled with the stored liquid drug. In various embodiments, thepatient can load a prefilled cartridge into the drug delivery device100. Further, in various embodiments, the primary drug container 202 canbe accessible for filling or refilling through a port provided on thedrug delivery device 100. Prior to activation of the drug deliverydevice 100, the primary drug container 202 can maintain the storedliquid drug. That is, the liquid drug can be sealed or contained withinthe primary drug container 202. Once the drug delivery device 100 isactivated, the liquid drug stored in the primary drug container 202 canbe accessed to provide the stored liquid drug to the patient.

The primary drug container access mechanism or component 204 can becoupled to the primary drug container 202. The primary drug containeraccess mechanism 204 can provide access to the liquid drug stored in theprimary drug container 202. When activated, the primary drug containeraccess mechanism 204 can couple the stored liquid drug to the needleconduit 206. In various embodiments, the primary drug container accessmechanism 204 can pierce a sealable end of the primary drug container,thereby obtaining access to the stored liquid drug.

The needle conduit 206 can include tubing or other fluid deliverymechanisms for transferring the stored liquid drug retained in theprimary drug container 202 to the needle insertion mechanism 208. Theneedle conduit 206 can be routed around any internal portion of the drugdelivery device 100. The needle conduit 206 can be formed, for example,from plastic tubing, metal tubing (e.g., stainless steel tubing), or acombination thereof. In general, the needle conduit 206 can provide afluid path for the liquid drug when expelled from the primary drugcontainer 202.

The needle insertion mechanism or component 208 can provide access tothe patient. For example, the needle insertion mechanism 208 can includea needle and/or a cannula for providing access to a patient and forproviding a path for delivering the liquid drug to the patient. Theneedle insertion mechanism 208 can include a hard needle that can bemaintained in a retracted mode inside of the drug delivery device 100prior to activation. Once activated, the needle insertion mechanism 208can extend the hard needle into the patient. The hard needle can then beretracted while leaving a cannula or soft needle inside of the patient.The soft needle of the needle insertion mechanism 208 can be coupled tothe needle conduit 206. Accordingly, after activation, a complete pathfrom the primary drug container 202 to the needle insertion mechanism208 through the needle conduit 206 can be provided.

Once a complete fluid path for the liquid drug is provided, the drivemechanism 210 can be used to expel the liquid drug from the primary drugcontainer 202 for delivery to the patient. For example, the drivemechanism 210 can be used to expel a desired amount of the liquid drugthat is to be provided to the patient over a certain amount of time. Invarious embodiments, the drive mechanism 210 can operate and control aplunger that can expel a portion of the liquid drug from the primarydrug container 202 based on the movement of the plunger. In variousembodiments, the flow of the liquid drug to the patient can be based onthe drive mechanism 210 and other factors such as the size (e.g.,diameter and length) of the needle conduit 206 to the patient.

The user control/interaction mechanism or component 212 can include anynumber of patient input elements or components including, for example,one or more buttons, triggers, knobs, switches, and/or sliding features.The user control/interaction mechanism 212 can be positioned on anyouter surface of the drug delivery device 100. The usercontrol/interaction mechanism 212 can be used to activate initialoperation of the drug delivery device 100. For example, by interactingwith the user control/interaction mechanism 212, a patient can initiateinsertion of the hard needle and/or soft needle of the needle insertionmechanism 208 into the patient. Further, the patient can initiate accessto the liquid drug stored in the primary drug container 202 by theprimary drug container access mechanism 204. Additionally, the patientcan initiate activation of the drive mechanism 210 to initiate deliveryof the stored liquid drug from the primary drug container 202 to thepatient.

In various embodiments, the user control/interaction mechanism 212 canbe used to start, stop, and/or restart delivery of the liquid drug tothe patient. In various embodiments, the user control/interactionmechanism 212 can be used to initiate delivery of the liquid drug to thepatient in a single dose. In various embodiments, the usercontrol/interaction mechanism 212 can be used to initiate delivery ofthe liquid drug to the patient over multiple doses (e.g., multiplediscrete doses). In various embodiments, one or more elements of theuser control/interaction mechanism 212 can be used to control operationof the drug delivery device 100 (e.g., starting and stopping delivery ofthe liquid drug using separate buttons of the user control/interactionmechanism 212). In various embodiments, operation of the drug deliverydevice 100 can be automated based on use of the user control/interactionmechanism 212.

The patient (or user) adherence mechanism 214 can be used to couple thedrug delivery device 100 to the patient. As mentioned, the patientadherence mechanism 214 can include an adhesive for attaching the drugdelivery device 100 to the patient. For example, the drug deliverydevice 100 can include an adhesive strip or pad positioned on the lowerportion 104 of the drug delivery device to facilitate adherence to apatient (e.g., a “peel and stick” adherence mechanism). In variousembodiments, the patient adherence mechanism 214 can include one or morefeatures for coupling to another device coupled to the patient. The usercontrol/interaction mechanism 212 can be used to engage or disengage thedrug delivery device 100 to any secondary device coupled to the patient.

The constituent components of the drug delivery device 100 depicted inFIG. 2 can be mechanically designed and operated. That is, theconstituent components of the drug delivery device 100 depicted in FIG.2 can be operated to deliver a stored liquid drug to a patient in one ormore doses over a desired amount of time without the use of anyelectrical components or an electrical power source. As a result, amechanical implementation of the drug delivery device 100 can beprovided in a cost-effective and reliable manner.

FIG. 3 illustrates a second exemplary embodiment 300 of the variousfunctional components of the drug delivery device 100. FIG. 3 canrepresent the various functional components of the drug delivery device100 when implemented as an electromechanical device (e.g., including thefunction and operation of the constituent components of the drugdelivery device 100). The functional components depicted in FIG. 3 canbe contained or positioned within the drug delivery device 100 (e.g.,contained within the top portion 102 and the lower portion 104).

As shown in FIG. 3, the exemplary embodiment 300 can include thefunctional components included in the exemplary embodiment 200: aprimary drug container 202, a primary drug container access mechanism orcomponent 204, a needle conduit 206, a needle insertion mechanism orcomponent 208, a drive mechanism or component 210, a user control and/orinteraction mechanism or component 212, and a patient adherence orcoupling mechanism or component 214. Each of these components can beimplemented as mechanical or electromechanical components. The exemplaryembodiment 300 can further include a controller 302, a memory 304, asensor 306, an additional user interface 308, and a communicationsinterface 310.

The memory 304 can be coupled to the controller 302. The controller 302can include one or more processors. The controller 302 can implement anysoftware, code, or instructions stored in the memory 304. The sensor 306can be any type of sensor. In various embodiments, the sensor 306 caninclude any type of sensor for monitoring a condition of the patient orfor monitoring operation of the drug delivery device 100. For example,the sensor 306 can be flow sensor, a viscosity sensor, a sensor fordetermining a positioning of a plunger of the drug delivery device 100,a sensor for determining an amount of liquid drug delivered to the user,a sensor for determining how much liquid drug remains in the drugdelivery device 100, a Hall effect sensor, and or a photogate. Thesensor 306 can also be a temperature sensor, an electrocardiography(ECG) sensor, a blood pressure sensor, a blood glucose sensor, or anyother type of patient biometric sensor.

The user interface 308 can include, for example, a touchscreen, a liquidcrystal display (LCD), light emitting diode (LED) display, or any othertype of display for presenting information to the patient and/orreceiving an input from the patient. The user interface 308 can alsoinclude interfaces for providing feedback or an output to the patientsuch as haptic feedback (e.g., vibrational feedback) or an audio orvisual output. In general, the user interface 308 can include one ormore interfaces for displaying or providing information to the patientand/or receiving information from the patient.

The communications interface 310 can include any type of communicationsinterface for communicatively coupling the drug delivery device 100 toan external or remote device. In various embodiments, the communicationsinterface 310 can include a wireless or wired communications interfaceoperating according to any wired or wireless communications standard. Invarious embodiments, the communications interface 310 can include aBluetooth, Bluetooth Low Energy, and/or WIFI communications interface.The communications interface 310 can also include a wired interface suchas a USB interface. Information or data related to the operation of thedrug delivery device 100 or state of the patient can be conveyed fromthe drug delivery device 100 to a remote device (e.g., a mobile device,tablet, computer, or smartphone) coupled to the communications interface310. Further, data collected or monitored by the sensor 306 can beprovided to a remote device by way of the communications interface 310.Such data can also be stored by the memory 304. Operation of the drugdelivery device 100 can be controlled or adjusted by a remote devicecoupled to the drug delivery device 100 by the communications interface310.

The controller 302 can be coupled to any other component of the drugdelivery device 100. The controller 302 can monitor the status of anyother component of the drug delivery device 100 and can control theoperation of any component of the drug delivery device 100. Thecontroller 302 can determine the operation of the drug delivery device100 based on, for example, patient input provided through the usercontrol/interaction mechanism 212 and/or the user interface 308.Overall, the controller 302 can operate to activate the drug deliverydevice 100—for example, to initiate activation of the needle insertionmechanism 208 and the primary drug container access mechanism 204 tobegin delivery of the stored liquid drug to the patient. Further, thecontroller 302 can stop (and restart) delivery of the liquid drug to thepatient—either automatically or subject to patient control—to facilitatedelivery of the liquid drug over multiple doses.

In various embodiments, one or more of the controller 320, the memory304, the sensor 306, the user interface 308, and the communicationsinterface 310 can be positioned or contained within the housing of thedrug delivery device 100. In various embodiments, one or more of thecontroller 320, the memory 304, the sensor 306, the user interface 308,and the communications interface 310 can be positioned or containedwithin the housing of the drug delivery device 100 can be provided on anelectronics connectivity module that can be coupled to the drug deliverydevice 100. For example, the electronics connectivity module can beinserted into the drug delivery device 100.

In various embodiments, the controller 302 can provide audible, visual,and/or haptic-based alarms and reminders to the patient. Further, thecontroller 302 can monitor and store dosing information (e.g., in thememory 304) including predetermined or preprogrammed dosing schedulesand actual dosing schedules. In general, the controller 302 can operateas a timer to control dosing. Information regarding dosages (e.g., timesand amounts) can be stored in the memory 304. Further, thecommunications interface can be coupled to any type of remote deviceeither directly (e.g., over a wired or wireless commutations interface310) or indirectly (e.g., over a cloud-based or other network-basedcommunications link).

Each of the individual components shown in FIG. 3—the primary drugcontainer 202, the primary drug container access mechanism 204, theneedle conduit 206, the needle insertion mechanism 208, the drivemechanism 210, the user control and/or interaction mechanism 212, andthe patient adherence or coupling mechanism 214—can function and operateas described in relation to FIG. 2 and/or can include electrical and/orelectromechanical features and can enable control by the controller 302.

The drug delivery device 100—including the functional components of thedrug delivery device 100 depicted in FIGS. 2 and 3—can operate accordingto a number of operational states. In various embodiments, the drugdelivery device 100 can include an idle state. In the idle state, thedrug delivery device 100 can maintain the stored liquid drug in theprimary drug container 202. The idle state can represent a state ofoperation prior to accessing the patient using the needle insertionmechanism 204 and prior to accessing the primary drug container 202using the primary drug container access mechanism 204. Accordingly,while in the idle state, the needle conduit 206 can remain decoupledfrom the stored liquid drug.

From the idle state, the drug delivery device 100 can enter anactivation state. The drug delivery device 100 can enter the activationstate based on patient input or can enter the activation stateautomatically without patient input. During a first portion of theactivation state (e.g., initial activation), the needle insertionmechanism 208 can provide access to the patient. Further, the primarydrug container access mechanism 204 can provide access to the liquiddrug stored in the primary drug container 202. As a result, the needleconduit 206 can be coupled to the stored liquid drug such that theliquid drug can be provided to the needle insertion mechanism 208.

During a second portion of the activation state (e.g., delivery), thedrive mechanism 210 can help expel the liquid drug from the primarystorage container 202, through the needle conduit 206, and on to theneedle insertion mechanism 208 for delivery to the patient. The drivemechanism 210 can be operated based on patient input and/or can beoperated automatically.

FIG. 4 illustrates a top view of the drug delivery device 100. As shownin FIG. 4, the patient interaction element 108 can be positioned on thetop surface of the top portion 102. The patient interaction element 108can be positioned along any portion of a top surface of the top portion102 (or along any portion of the drug delivery device 100). The raisedportion 106 is shown positioned along a periphery of the top surface ofthe top portion 102 but is not so limited. That is, the raised portion106 can be positioned along any portion of the top surface of the topportion 102 (or along any portion of the drug delivery device 100).

FIG. 5 illustrates a first side view of the drug delivery device 100. Asshown in FIG. 5, the drug delivery device 100 can include a protrusion502. The protrusion 502 can extend from the bottom portion 104 of thedrug delivery device 100. The protrusion 502 can extend from along anyportion of the bottom portion 104 of the drug delivery device 100. Theprotrusion 502 can be of any length and can extend below the bottomportion 104 by any amount. The protrusion 502 can be a portion of theneedle insertion mechanism 208 depicted in FIGS. 2 and 3. In variousembodiments, the protrusion 502 can be a soft needle or cannula thatextends from the drug delivery device 100 into the patient once a hardneedle of the needle insertion mechanism 208 has been retracted backinside the drug delivery device 100. The protrusion 502 can extend belowthe bottom portion 104 when attached to a patient and when delivering aliquid drug to the patient. The bottom portion 104 of the drug deliverydevice 100 can include a port or opening allowing for extension of thehard and soft needle and retraction of the hard needle of the needleinsertion mechanism 208. In various embodiments, the protrusion 502, asa soft needle, can remain extended outside of the drug delivery device100 after activation. Accordingly, the drug delivery device 100 canprovide sharps protection as no sharp or hard needle remains extendedfrom the drug delivery device 100. Prior to activation, the protrusion502 can be positioned within the drug delivery device 100 (e.g., so asnot to extend below the lower portion 104). The first side view of thedrug delivery device 100 shown in FIG. 5 illustrates the raised portion106 positioned on a first side of the drug delivery device 100.

FIG. 6 illustrates a second side view of the drug delivery device 100.As shown in FIG. 6, the protrusion 502 extends below the lower portion104. FIG. 7 illustrates a bottom view of the drug delivery device 100.As shown in FIG. 7, the bottom portion 104 of the drug delivery device100 can include an opening or a port 702. The opening 702 can provide aspace for a hard needle, soft needle, or other element of the needleinsertion mechanism 208 to extend from inside of the drug deliverydevice 100 beyond the bottom portion 104. The opening 702 can also allowthe hard (e.g., sharp) needle of the needle insertion mechanism 208 toretract back inside of the drug delivery device 100. As a result, thehard needle can remain above the lower portion 104 such that no sharpportion of the needle insertion mechanism 208 extends through theopening 702 and/or below the lower portion 104 of the drug deliverydevice 100.

FIG. 8 illustrates an exemplary method of operation 800 for the drugdelivery device 100. At 802, the drug delivery device 100 can be coupledto a patient. The drug delivery device 100 can be coupled directly to apatient such that a hard needle, soft needle, and/or cannula of theneedle insertion mechanism 208 can make contact with the patient whenextended from the drug delivery device 100. The drug delivery device 100can be coupled to a patient by, for example, the patient adherencemechanism 214. When coupled to the patient, the lower portion 104 of thedrug delivery device 100 can be in direct contact with the patient.

At 804, the drug delivery device 100 can be activated. Prior toactivation, the drug delivery device 100 can be maintained in an idle orwaiting state when coupled to the patient. The drug delivery device 100can be activated manually or automatically. In various embodiments, thedrug delivery device 100 can be activated by a patient interacting witha patient control feature positioned on the drug delivery device 100such as, for example, the patient control/interaction mechanism 212.

After activation, at 806, a needle of the drug delivery device 100 canbe inserted into the patient. The needle can be a soft needle and can bea part of the needle insertion mechanism 208 of the drug delivery device100. A hard needle can be inserted into the patient and then beretracted, leaving the soft needle or cannula coupled to the patient.The insertion and retraction of the hard needle and the placement of thesoft needle or cannula in the patient can be triggered by the activationat 804. The needle insertion mechanism 208 can be considered to providean access point to the patient for delivering the liquid drug to thepatient.

After activation, at 808, the primary drug container 202 storing aliquid drug can be accessed. The primary drug container 202 can beaccessed by the primary drug container access mechanism 204. Any portionof the primary drug container 202 can be accessed. In variousembodiments, the primary drug container 202 can have two sealed ends,with either end providing access to the liquid drug at 808. Access tothe primary drug container 202 can be triggered by the activation at804. Steps 806 and 808 can be implemented in any order and are notlimited to being implemented in the order as shown in FIG. 8. Further,steps 806 and 808 can occur approximately simultaneously at the time ofactivation at 804 and can be considered to be further steps of theactivation step 804.

After activation—for example, after needle insertion at 806 andaccessing the primary drug container 202 at 808—the liquid drugcontained in the primary drug container 202 can be in fluidcommunication with the needle conduit 206, which can couple the liquiddrug to the needle insertion mechanism 208. In various embodiments, at808, a complete fluid path from the primary drug container 202 to thepatient can be established (e.g., by the needle conduit 206 and theneedle insertion mechanism 208). Subsequent operation of the drugdelivery device 100 can regulate the flow of the liquid drug includingstarting, stopping, and restarting the flow of the liquid drug to thepatient.

At 810, the liquid drug can be delivered to the patient. The liquid drugcan be provided from the primary drug container 202, to the needleconduit 206, and on to the needle insertion mechanism 208 for deliveryto the patient. Any amount of liquid drug can be delivered to thepatient over any desired amount of time over one or more doses separatedby any amount of time. At 810, the drive mechanism 210 can drive theliquid drug from the primary drug container 202 to the needle conduit206. Operation of the drive mechanism 210, and consequently the deliveryof the liquid drug to the patient, can be controlled by patient inputand/or a controller to enable manual and/or automatic control.

At 812, the operation of the drug delivery device 100 can be controlledas desired to start, stop, and restart delivery of the liquid drug tothe patient as desired. For example, the patient can stop operation ofthe drug delivery device 100 after a first dose of the liquid drug hasbeen delivered to the patient and can then restart operation of the drugdelivery device 100 to provide a subsequent dose of the liquid drug tothe patient. Operation of the drive mechanism 210 can control the dosingof the liquid drug to the patient as described in relation to 810.

FIG. 9 illustrates a second exemplary embodiment of a drug deliverydevice 900. The drug delivery device 900 can operate and providesubstantially the same functionality as the drug device 100. As shown inFIG. 9, the drug delivery device 900 can include a top or upper portion902 and a lower portion or base 904. The top portion 902 and the lowerportion 904 can together form a housing of the drug delivery device 900.The top portion 902 and the lower portion 904 can be coupled together toform an outside of the drug delivery device 900. The drug deliverydevice 900 can represent another design or form factor of the drugdelivery device 100.

The drug delivery device 900 can include an opening 906 that can exposea portion of a primary drug container (e.g., a cartridge) positionedwithin the drug delivery device 900. The opening 906 can allow visualinspection and monitoring of the primary drug container. For example, apatient of the drug delivery device 900 can monitor an amount of liquiddrug remaining in the primary drug container. In this way, a patient canmonitor dosing status. The opening 906 can also enable a patient toinspect the liquid drug for particles or discoloration. The opening 906can be covered with a clear material such as plastic to allow a viewingof the primary drug container. The opening 906 can be of any size orshape and can be positioned along any portion of the drug deliverydevice 900.

The top portion 902 of the drug delivery device 900 can include apatient interaction element or component 908. In various embodiments,the patient interaction element 908 can be a push button. In variousembodiments, the patient interaction element 908 can correspond to thepatient interaction element 108. The patient interaction element 908 canbe used to activate the drug delivery device 900. For example, when apatient presses on the patient interaction element 908, the drugdelivery device 900 can begin delivering the stored liquid drug to thepatient. In various embodiments, the patient interaction element 908 canbe used to start and stop delivery of the liquid drug to the patient toenable a patient to dispense multiple doses of the liquid drug.

In various embodiments, the drug delivery device 900 can include two ormore patient interaction elements. In various embodiments, the drugdelivery device 900 can also include an on-body interlock device (notshown in FIG. 9).

FIG. 10 illustrates a top view of the drug delivery device 900. As shownin FIG. 10, the opening 906 can be positioned on a side of the upperportion 902 of the drug delivery device. The opening 906 can bepositioned along any portion of the upper portion 902.

FIG. 11 illustrates a first side view of the drug delivery device 900.As shown in FIG. 11, the drug delivery device 900 can include aprotrusion 1102. The protrusion 1102 can be a soft needle that canextend from the bottom portion 904 of the drug delivery device 900. Theprotrusion 1102 can be part of the needle insertion mechanism of thedrug delivery device 900. The protrusion 1102 can extend below thebottom portion 902 when attached to a patient and when delivering aliquid drug to the patient. The protrusion 1102 can correspond to theprotrusion 502. The protrusion 1102 can be positioned along any portionof the bottom portion 904. The protrusion 1102 can be of any length andcan extend below the bottom portion 904 by any amount.

As further shown in FIG. 11, the drug delivery device 900 can include anon-body interlock 1104. The on-body interlock 1104 can also extend fromthe bottom portion 904 along any portion of the bottom portion 904. Theon-body interlock 1104 can be a button or switch that can retract intothe drug delivery device 900 when the lower portion 904 is coupled tothe patient.

The on-body interlock device 1104 can be required to be depressed (e.g.,passively) before the drug delivery device 900 can be activated. Forexample, when the drug delivery device 900 is coupled to a patient, theon-body interlock device 1104 can be passively depressed. Oncedepressed, the patient interaction element 108 can subsequently be usedto activate the drug delivery device 900. Prior to the on-body interlock1104 being depressed, the patient interaction element 108 can bedisengaged such that manipulation of the patient interaction element 108does not activate the drug delivery device 900.

The on-body interlock 1104 can also stop operation of the drug deliverydevice 900. For example, when the drug delivery device 900 is removedfrom a patient, the on-body interlock 1104 can be biased to extend fromthe lower portion 904. When so extended, the on-body interlock 1104 canplace the drug delivery device 1104 into a stopped or idle state ofoperation that prevents or stops delivery of the liquid drug to thepatient.

The on-body interlock 1104 can be any component that can be biased toextend from the drug delivery device 900 and that can be retractedinside of the drug delivery device 900 when a force is applied. As shownin FIG. 11, the on-body interlock 1104 can be implemented as a pivotingcomponent, biased to remain outside of the drug delivery device 900 andto pivot into the drug delivery device 900 when passively depressed. Invarious other embodiments, the on-body interlock 1104 can be implementedas a push rod.

As further shown in FIG. 11, the opening 906 can be positioned a side ofthe upper portion 906. The opening 906 can be of any size and/or shape.The opening 906 can have any width or height.

FIG. 12 illustrates a second side view of the drug delivery device 900.As shown in FIG. 12, the protrusion 1102 and the on-body interlock 1104extend form the lower portion 904 of the drug delivery device 900.

FIG. 13 illustrates a bottom view of the drug delivery device 900. Asshown in FIG. 13, the bottom portion 904 of the drug delivery device 900can include an opening or a port 1302. The opening 1302 can correspondto the opening 702. A positioning of the on-body interlock 1104 is alsoshown in FIG. 13.

FIG. 14 illustrates a third exemplary embodiment of a drug deliverydevice 1400. The drug delivery device 1400 can operate and providesubstantially the same functionality as the drug device 100 and/or thedrug delivery device 900. As shown in FIG. 14, the drug delivery device1400 can include a top portion 1402 and a bottom portion 1404. The topportion 1402 and the bottom portion 1404 can together form a housing ofthe drug delivery device 1400. The top portion 1402 and the bottomportion 904 can be coupled together to form an outside of the drugdelivery device 1400. The drug delivery device 900 can represent anotherdesign or form factor of the drug delivery device 100 and/or the drugdelivery device 900.

The drug delivery device 1400 can include an opening or window 1406 thatcan expose a portion of a primary drug container and/or cartridgepositioned within the drug delivery device 1400. The opening 1406 cancorrespond to the opening 906. The top portion 1402 can also include apatient interaction element or component 1408. In various embodiments,the patient interaction element 1408 can be a push button. In variousembodiments, the patient interaction element 912 can correspond to thepatient interaction element 108 and/or the patient interaction element908. The drug delivery device 1400 can also include an on-body interlockpositioned on an underside of the bottom portion 1404 (not shown in FIG.14).

FIG. 15 illustrates a first exemplary arrangement of internal componentsof the drug delivery device 100. For example, FIG. 15 shows variousinternal components of the drug delivery device 100 when the top portion102 of the drug delivery device 100 is removed. The internal componentsshown in FIG. 15 can be substantially the same as and/or representativeof the internal components of any other drug delivery devices disclosedherein including the drug delivery device 900 and the drug deliverydevice 1400. The arrangement and positioning of the internal componentsis not limited to that shown in FIG. 15.

As shown in FIG. 15, the drug delivery device 100 can include a primarydrug container 1502. The primary drug container 1502 can include a firstend 1504 and a second end 1506. The primary drug container 1502 can besealed at or near the first end 1504 and the second end 1506. Theprimary drug container 1502 can be formed from glass and/or plastic. Thefirst end 1504 can include a neck and a cap as shown. The second end1506 can include a plunger 1508. The plunger 1508 can be formed from aplastic material such as, for example, an elastomeric polymer material.A liquid drug 1510 can be contained between a sealing arrangementprovided at the first end 1504 of the primary drug container 1502 andthe plunger 1508. As an example, the first end 1504 of the primary drugcontainer 1502 can be sealed by a septum (e.g., as shown in FIG. 41).The primary drug container 1502 of the drug delivery device 100 can be adrug cartridge such as, for example, an ISO standardized drug cartridge.The primary drug container 1502 can correspond to the primary drugcontainer 202 described in relation to FIGS. 2 and 3.

The liquid drug 1510 contained within the primary drug container 1502can be accessed through either the first end 1504 or the second end1506. As shown in FIG. 15, the liquid drug 1510 is accessed through thesecond end 1506 of the primary drug container 1502. A primary drugcontainer access mechanism or component 1512 can be positioned at ornear the second end 1506 for accessing the liquid drug 1510. As shown inFIG. 15, the primary drug container access mechanism 1512 can access theliquid drug 1510 through the plunger 1508. The primary drug containeraccess mechanism 1512 can include a needle or other component to piercethe plunger 1508 to access the liquid drug 1510. Prior to piercing theplunger 1508, the plunger 1508 can remain unpierced and the liquid drug1510 inaccessible and sealed within the primary drug container 1502. Theprimary drug container access mechanism 1512 can remain in an idle stateprior to being activated to access the liquid drug 1510. Afteractivation, the needle of the primary drug container access mechanism1512 can extend through the plunger 1508 as shown in FIG. 15.

The primary drug container access mechanism 1512 can couple the liquiddrug 1510 to a needle conduit 1514. The needle conduit 1514 can includetubing (e.g., plastic tubing or metal tubing) and can provide a path fora portion of the liquid drug 1510 that is expelled from the primary drugcontainer 1502. The primary drug container access mechanism 1512 cancorrespond to the primary drug container access mechanism 204 describedin relation to FIGS. 2 and 3. The needle conduit 1514 can correspond tothe needle conduit 206 described in relation to FIGS. 2 and 3. Invarious embodiments, the needle used to pierce the plunger 1508 can be apart of the needle conduit 1514 as opposed to a portion of the primarydrug container access mechanism 1512.

In various embodiments, the liquid drug 1510 can be accessed through thefirst end 1504 of the primary drug container 1502. In variousembodiments, the primary drug container access mechanism 1512 can bepositioned at or near the first end 1504 along with the needle conduit1514.

As shown in FIG. 15 and described herein, the liquid drug 1510 stored inthe primary drug container 1502 can be accessed through the primary drugcontainer access mechanism 204 without having to move the primary drugcontainer 1502.

The needle conduit 1514 can route the liquid drug 1510 from the primarydrug container 1502 to a needle insertion mechanism or component 1516.The needle insertion mechanism 1516 can provide an entry point to apatient. The needle insertion mechanism 1516 can include a hard needleand/or a soft needle or cannula that provides access to the patient suchthat the liquid drug 1510 can be delivered to the patient. The needleinsertion mechanism 1516 can correspond to the needle insertionmechanism 208 described in relation to FIGS. 2 and 3.

As further shown in FIG. 15, the drug delivery device 100 can include adrive spring 1518 and a number of spherical elements or components 1520(e.g., a plurality of spherical elements or spheres 1520). The sphericalelements 1520 can be referred to as spherical energy transfer elementsor components, or force transfer spheres. As used herein, the sphericalelements 1520 can be referenced using any of these terms including, forexample, spheres 1520. In various embodiments, the spheres 1520 can beball bearings. The spheres 1520 can be formed of any type of materialincluding glass, metal (e.g., stainless steel), or a polymer or otherplastic.

The drive spring 1518 and the spheres 1520 can be used to expel theliquid drug 1510 from the primary drug container 1502. In particular,the drive spring 1518 can apply a force that can be applied to thespheres 1520. The spheres 1520 can be arranged to transfer the forcefrom the drive spring 1518 to the plunger 1508. When the force from thedrive spring 1518 is applied to the plunger 1508, the plunger 1508 canadvance into the primary drug container 1502 (toward the first end1504). As the plunger 1508 advances into the primary drug container1502, the liquid drug 1510 within the primary drug container 1502 can beforced out of the primary drug container 1502 into the needle conduit1514 and on to the needle insertion mechanism 1516 for delivery to thepatient. In particular, as the plunger 1508 is moved toward to the firstend 1504, the liquid drug 1510 can be forced out of the primary drugcontainer 1502 through the plunger 1508 on to the needle conduit 1514.Accordingly, in various embodiments, the liquid drug 1510 can beexpelled from the primary drug container 1502 in a direction that isapproximately opposite to a direction of movement of the plunger 1508 asthe plunger 1508 is moved toward the first end 1504.

The drive spring 1518 can be any type of spring. The drive spring 1518can have any desired spring constant value, k. The drive spring 1518 isnot limited to a single spring and can include one or more springs. Invarious embodiments, the drive spring 1518 can include one or morecompression springs and/or torsion springs. For example, the drivespring 1518 can include one or more linear compression springs arrangedin a parallel arrangement, a series arrangement, an arrangement ofnested springs in series, or any combination thereof. In variousembodiments, the drive spring 1518 can be implemented as double seriessprings. A dead bolt 1522 or other fixed element can be positioned atone end of the drive spring 1518. The dead bolt 1522 can provide astable reference for the drive spring 1518 (e.g., a push off point). Thedead bolt 1522 can be considered a thrust point for the drive spring1518 (e.g., a force reactionary “thrust point”). The dead bolt 1522 canbe considered to be or can represented a fixed component that can becoupled to the inner top surface of the lower portion 104. The fixedcomponent 1522 can be positioned at an end of the drive spring 1518.

As shown in FIG. 15, the drive spring 1518 can be directly coupled tothe spheres 1520. In various embodiments, the drive spring 1518 caninclude a fixed component or plate coupled to an end of the drive spring1518. The fixed component can have a width that is substantially thesame as the width of the coils of the coils of the drive spring 1518.The fixed component can be substantially flat and can be directlycoupled to the spheres 1520 (e.g., the sphere 1520 positioned furthestfrom the plunger 1508 along the path of the spheres 1520.

The bottom portion 104 can include a track 1524 for guiding the spheres1520. The track 1524 can be considered to be a guide, tube, or housing.In various embodiments, the drive spring 1518 and the spheres 1520 canbe positioned within the track 1524. The track 1524 can completelysurround or cover the drive spring 1518 and/or the spheres 1520. Thetrack 1524 can be formed of any type of material including, for example,a plastic material or metal (e.g., stainless steel), or any combinationthereof. For example, an outer portion of the curved portion of thetrack 1524 may be formed of a metal while an inner portion of the curvedportion of the track may before formed of a hard plastic. The track 1524can form any shape and can be arranged to take on any shape to guide thespheres 1520 from the drive spring 1518 to the cartridge 1502. Invarious embodiments, a first end of the track 1524 can be positionedadjacent to the dead bolt 1522 and a second end of the track 1524 can bepositioned approximately adjacent to the second end 1506 of thecartridge. The first end of the track 1524 can be closed while thesecond end of the track 1524 can be open, to allow the spheres 1520 toexit the track 1524 and to enter the primary drug container 1502 asshown in FIG. 15. The track 1520 can provide a support or guide for thedrive spring 1518. This can increase the efficiency of the drug deliverydevice 100 as the drive spring 1518 can be prevented from buckling ordeforming during expansion (e.g., when the drug delivery device 100 isin motion due to movement of the patient).

In various embodiments, the track 1524 can cover any portion of thedrive spring 1518 (e.g., less than the entirety of the drive spring1518). In various embodiments, the track 1524 can have anycross-sectional shape. For example, the track 1524 can have a circularcross-sectional shape. Overall, the track 1524 can provide a desiredarrangement and/or alignment of the spheres 1510 relative to the drivespring 1518 and the primary drug container 1502. Further, the track 1524can ensure that the spheres 1520 are moved toward the cartridge 1502 bythe drive spring 1518. In various embodiments, the drive spring 1518 canbe extend into the primary drug container 1502.

The spheres 1520 can be arranged between the drive spring 1518 and theprimary drug container 1502. In various embodiments, the spheres 1520can be positioned adjacent to the primary drug container 1502, theprimary drug container access mechanism 1512, and/or the plunger 1508.The spheres 1520 can be arranged to follow any path or route (e.g., asdetermined by the track 1524). The spheres 1520 can be considered asforming a ball chain. As an alternative to the spheres 1520, or inaddition thereto, the drive mechanism 210 of a drug delivery devicedescribed herein can include chains, linkages, or other flexible orsemi-flexible elements or components for translating a force form asource (e.g., the drive spring 1518) to the plunger 1508. In variousembodiments, one or more rigid elements can be used transfer a force tothe plunger 1508. In general, any combination of spheres 1520, flexible,semi-flexible, and/or rigid elements can be used to transfer a force tothe plunger 1508.

Prior to activation, the drive spring 1518 can remain in an idle state.While in an idle state, the drive spring 1518 can be compressed (e.g.,as shown in FIG. 15). When activated, the drive spring 1518 can beallowed to expand. For example, after activation, the drive spring 1518can be allowed to expand in a direction away from the dead bolt 1522.The drive spring 1518 can be allowed to fully expand at one time or canbe incrementally expanded so as to apply a force to the plunger 1508through the spheres 1520 in an incremental manner. When initiallyactivated, the drive spring 1518 can apply a force that enables theprimary drug container access mechanism 1512 to access the liquid drug1510. For example, the drive spring 1518 can apply a force that enablesthe primary drug container access mechanism 1512 to cause a needlecoupled to the needle conduit 1514 to pierce the plunger 1508. The drivespring 1518 and the spheres 1520 can together correspond to the drivemechanism described in relation to FIGS. 2 and 3.

Once the plunger 1508 is pierced, the primary drug container 1502 can bedrained of its contents and delivered to a patient. The liquid drug 1510contained in the primary drug container 1502 can be drained at anydesired rate over any amount of time over one or more doses. The liquiddrug 1510 can be expelled from the primary drug container 1502 at onetime (e.g., for a single dose delivery) or can be expelled over a seriesof start and stop intervals (e.g., for multiple dose delivery). Thespheres 1520 and track 1524 can be used to transfer energy stored by thedrive spring 1518 to the plunger 1508. Accordingly, the drive spring1518 can be considered to be an energy storage mechanism or componentand the spheres 1520 can be considered to be an energy transfermechanism or component. The drive mechanism of the drug delivery device100 can therefore be considered to include both an energy storagemechanism or component and an energy transfer mechanism or component.Any number of spheres 1520 can be used between the drive spring 1518 andthe primary drug container 1502.

The drive spring 1518 and the spheres 1520 can be selected and adjustedto help regulate a flow of the liquid drug 1510 from the primary drugcontainer 1502 to the needle insertion mechanism 1516 based on a varietyfactors including the viscosity of the liquid drug 1510. The needleconduit 1514 can be arranged as shown in FIG. 15 to provide a serviceloop that allows flexing to improve delivery and flow of the liquid drug1510 to the patient.

In general, the drug delivery devices described herein can operates asfollows. The plunger 1508 can be moved toward the first end 1504 of theprimary drug container 1502 to expel the liquid drug 1510 from theprimary drug container 1502. The liquid drug 1510 expelled from theprimary drug container 1502 can be provided to a needle conduit 1514.The needle conduit 1514 can be coupled to a needle insertion mechanism1516 that can provide an access point to the patient. The needle conduit1514 can be coupled to the plunger 1518 or can be coupled to a septum ofthe primary drug container 1502. The flow (e.g., speed) of the liquiddrug 1510 can be determined by a variety of factors including aviscosity of the liquid drug 1510, a length and size (e.g., internaldiameter) of the needle conduit 1514 and any fluid path portion of theneedle mechanism 1516, and the force provided by the drive spring 1518.Given a viscosity of for a particular liquid drug 1510, the forceprovided by the drive spring 1518 as well as parameters of the fluidpath (e.g., length and width of the provided fluid path through theneedle conduit 1514) can be tuned or adjusted to provide a desired flowrate. In particular, a desired flow rate of the liquid drug 1510. Inthis way, a particular liquid drug 1510 can be delivered to the patientover a desired amount of time. In various embodiments, flow restrictionscan be add to the fluid path (e.g., along any portion of the needleconduit 1514) to adjust flow of the liquid drug 1541 as desired. Theforce of the spring 1518 can be determined by the size and arrangementof the one or more springs used for the drive spring 1518 including thespring constants of the one or more springs.

In various embodiments, the drive spring 1518 can be maintained in acompressed state prior to activation. Once activated, the drive spring1518 can be allowed to expand and apply a force to the one or morespheres 1520. An initial force provided by the drive spring 1518 cancause the primary drug container access mechanism 1512 to access theprimary drug container 1502. Specifically, the primary drug containeraccess mechanism 1512 can couple the liquid drug 1510 to the needleconduit—for example, by forcing a needle of the needle conduit 1514 topierce the plunger 1518.

To provide the liquid drug 1510 to the patient in a single dose, thedrive spring 1518 can be allowed to expand fully in substantially onemotion over a desired period of time. In doing so, the liquid drug 1510can be expelled from the primary drug container 1502 substantiallycontinuously. To provide the liquid drug 1510 to the patient over two ormore doses, application of the force from the drive spring 1518 to theplunger 1508 can be interrupted. For example, the drive spring 1518 canbe prevented from expanding and/or the spheres 1520 can be held backfrom advancing. By applying and interrupting the force from the drivespring 1518 to the plunger 1508, the liquid drug 1510 can be deliveredto the patient in multiple discrete amounts, thereby providing multipledoses of the liquid drug 1510 to the patient over time. The needleinsertion mechanism 1516 and/or the needle conduit 1514 can also blockthe flow of the liquid drug 1510 when desired to enable the liquid drug1510 to be delivered to the patient over multiple doses.

The spheres 1520 can provide efficient energy transfer from the drivespring 1518 to the plunger 1508 due in part to the spheres 1520providing point to point contact to one another. This point to pointcontact can introduce less friction into a drive system than a drivesystem that relies on line to line contact between elements fortransferring energy. Further, the drive mechanism of the drug deliverydevice 100 enables energy to be transferred in a different directionthan the energy is initially provided. For example, as shown in FIG. 15,the energy stored by the drive spring 1518 can be transferred around atight radius of curvature by the spheres 1520 (e.g., around a corner or180 degrees from the where the energy is first directed as shown by theexemplary arrangement of the track 1524). This enables the drug deliverydevice 100 to remain small and compact.

As shown in FIG. 15, a force can be provided by the drive spring 1518when it is allowed to expand. The force provided by the drive spring1518 can be applied in a direction 1530 toward the spheres 1520. Thedirection 1530 can correspond to a direction in which the drive spring1518 is allowed to expand, based on a positioning of the dead bolt 1522,which can provide a thrust point for the drive spring 1518. Withreference to the arrangement of the components shown in FIG. 15, thedirection 1530 of the force provided by the drive spring 1518 can befrom the dead bolt 1522 to the spheres 1520. The spheres 1520 cantranslate or transfer the force from the drive spring 1518 to theplunger 1508. The spheres 1520 allow the force to be translated to adifferent direction than the original direction of the force.Specifically, the spheres 1520 can apply the force in a direction towardthe first end 1504 of the primary drug container 1502 relative to thesecond end 1506 of the primary drug container 1502. Consequently, thespheres 1520 enable the force provide by the drive spring 1518 providedin a first direction to be applied to the plunger 1508 in a second,approximately opposite direction.

In particular, as shown in FIG. 15, the direction 1530 of the forceprovided by the drive spring 1518 can cause the spheres 1520 to move inthe direction 1532—that is, through the track 1524 toward the second end1506 of the primary drug container 1502 (e.g., clockwise). The spheres1520 can therefore transfer the force from the drive spring 1518 to theplunger 1508, thereby causing the plunger 1508 to move in a direction1540. The movement of the plunger 1508 in the direction 1540 can forcethe liquid drug 1510 out of the primary drug container 1502 and into theneedle conduit 1514.

Further, the spheres 1520 enable the plunger 1508 to move in a firstdirection from the second end 1506 of the primary drug container 1502 tothe first end 1504 of the primary drug container 1502. In doing so, theplunger 1508 can force, expel, or push the liquid drug 1510 out of theprimary drug container 1502 through the needle conduit 1514. As shown inFIG. 15, the needle conduit 1514 can be directly coupled to the plunger1508. As a result, the liquid drug 1510 can be expelled from the primarydrug container 1502 in a direction approximately opposite to a directionof the movement of the plunger 1508 toward the first end 1504 of theprimary drug container 1502. The direction of the expelled liquid drug1510 is approximately the same direction as the direction of the forceprovided by the drive spring 1518.

In general, the drug delivery device 100, and any other drug deliverydevice described herein, can generate a force in a first direction(e.g., the direction 1530 based on the drive spring 1518) and can applythe force in a second, opposite direction (e.g., the direction 1540based on the spheres 1520) to expel the liquid drug 1510 from a primarydrug container 1502 in a precise and controlled manner. The direction1540 need not be opposite to the direction 1530. That is, in variousembodiments, the direction 1540 of the force applied to the plunger 1508by the spheres 1520 can be in any direction relative to the direction1530 of the force provided by the drive spring 1518.

Further, in various embodiment, the liquid drug 1510 can be expelledfrom either end of the primary drug container 1502. This enables thecomponents of the drug delivery device 100 (as shown in FIG. 15) to bearranged in a close and tight manner, allowing the drug delivery device100 to remain small and compact. In turn, the drug delivery device 100can be more comfortable to wear and less cumbersome to the patient.

The drive spring 1518 and the spheres 1520 can be operated to enable anynumber of spheres 1520 or any portion of a single sphere 1520 to advancethe plunger 1508. In various embodiments, one stroke of delivery of theliquid drug 1510 can correspond to one sphere 1520. For example, thewidth or diameter 1526 of one sphere 1520 can correspond to one strokeof liquid drug 1510 delivery. In various embodiments, the widths 1526 ofthe spheres 1520 can all be approximately equal. By controlling thenumber of spheres 1520 or portion of any one sphere 1520 that can beadvanced into the primary drug container 1502 to push on the plunger1508, the drug delivery device 100 can provide the liquid drug 1510 to apatient in a single dose or over multiple doses.

As shown in FIG. 15, the primary drug container 1502 can have an innerdiameter 1528 (and an outer diameter; not shown in FIG. 15 forsimplicity). The inner diameter 1528 of the primary drug container 1502can be slightly larger than the diameter of the spheres 1520, therebyallowing the spheres 1520 to fit inside of the primary drug container1502. Further, the track 1524 can have an inner diameter (not shown inFIG. 15 for simplicity) that is also slightly larger than the diameter1526 of the spheres 1520, to also allow the spheres 1520 to move throughthe interior of the track 1524.

In various embodiments, the needle conduit 1514 can be a needle formedfrom plastic or metal, or a combination thereof. As shown in FIG. 15, anend of the need conduit 1514 that can be coupled to the liquid drug 1510can be a hard end of the needle conduit 1514 while the portion of theneedle conduit 1514 routed toward the needle mechanism 1516 can be asoft portion of the needle conduit 1514.

FIG. 16 illustrates a second exemplary arrangement of internalcomponents of the drug delivery device 100. For example, FIG. 16 showsvarious internal components of the drug delivery device 100 when the topportion 102 of the drug delivery device 100 is removed. The internalcomponents shown in FIG. 16 can be substantially the same as and/orrepresentative of the internal components of any other drug deliverydevices disclosed herein including the drug delivery device 900 and thedrug delivery device 1400. The arrangement and positioning of theinternal components is not limited to that shown in FIG. 16.

As shown in FIG. 16, the drug delivery device 100 includes a guide 1602.The guide 1602 can be a spring or coil guide. The guide 1602 can beformed of any material including plastic or metal. The guide 1602 cancontain and provide a route or an alignment for the spheres 1520. Theguide 1502 can be positioned between the drive spring 1518 and theprimary drug container 1502. The guide 1602 can extend into the primarydrug container 1502 to enable the spheres 1520 to make contact with theplunger 1508 as the drug delivery device 100 operates to deliver theliquid drug 1510 to the patient. Accordingly, in various embodiments,the guide 1502 can apply a force to the plunger 1508. In various otherembodiments, the guide 1602 does not apply any force to the plunger 1508and instead maintains an alignment and routing of the spheres 1520.

As shown in FIG. 16, the guide 1502 can include a first region 1604 anda second region 1606. When the drive spring 1518 is allowed to expand,the first region 1604 can be driven forward and can begin to collapse.The second region 1606 can begin to expand as the plunger 1508 is movedforward toward the first end 1504 of the primary drug container 1502.Accordingly, portions of the guide 1602 can be allowed to expand orcompress as appropriate based on its positioning relative to the drivespring 1518 and the plunger 1508 and based on the expanded state of thedrive spring 1518.

FIGS. 15 and 16 show the liquid drug 1510 of the primary drug container1502 as accessible through the plunger 1508. In various embodiments, theliquid drug 1510 of the primary drug container 1502 can be accessedthrough the first end 1504 of the primary drug container 1502, which mayinclude or may be referred to as the “septum” (e.g., as depicted anddescribed in relation to FIG. 41). In various embodiments, the primarydrug container access mechanism 1512 can be positioned at or near thefirst end 1504 of the primary drug container 1502. The primary drugcontainer access mechanism 1512 can access the liquid drug 1510 througha septum positioned at or near the first end 1504 of the primary drugcontainer 1502. In various embodiments, the primary drug container 1502can be held in a stationary position and the primary drug containeraccess mechanism 1512 can be moved relative to the primary drugcontainer 1502 to pierce the septum. In various embodiments, the primarydrug container access mechanism 1512 can be held in a stationaryposition and the primary drug container 1504 can be moved relative tothe primary drug container access mechanism 1512 to pierce the septum.Under either scenario, a force provided by the drive spring 1518 cancause the septum to be pierced, thereby coupling the liquid drug 1510 tothe needle conduit 1514. As shown in FIG. 16, the drive spring 1518 isshown with the fixed component or plate positioned at an end of thedrive spring 1518 and directly coupled to the spheres 1520. In variousembodiments, the drive spring 1518 as illustrated can be used as thedrive spring 1518 depicted in FIG. 15.

The various internal components of the drug delivery device 100 depictedin FIGS. 15 and 16 can be mechanically operated and controlled or can beelectromechanically operated and controlled. In various embodiments, theinternal components of the drug delivery device 100 depicted in FIGS. 15and 16 can be operated to deliver the liquid drug 1510 to the patient ina single dose. In various embodiments, the internal components of thedrug delivery device 100 depicted in FIGS. 15 and 16 can be operated todeliver the liquid drug 1510 to the patient in two or more doses (e.g.,in multiple doses).

To provide the liquid drug 1510 across multiple doses, the flow of theliquid drug 1510 can be stopped or interrupted such that it does notflow out of the primary drug container 1502, through the needle conduit1514, and/or through the needle insertion mechanism 1516. In general,multiple doses can be provided by interrupting the flow of the liquiddrug 1510 from the primary drug container 1520. The flow of the liquiddrug 1510 can be interrupted by removing the force applied to theplunger 1508 that can push the liquid drug 1510 out of the primary drugcontainer 1502. The force applied to the plunger 1508 can be interruptedby retaining the drive spring 1518 and/or by retaining the spheres 1520from applying any translated force from the drive spring 1518 to theplunger 1508. By alternatively applying and interrupting the forceapplied to the plunger 1508, the drug delivery device 100 can providethe liquid drug 1510 to the patient over multiple doses.

FIG. 17 illustrates an exemplary drive spring release mechanism orcomponent 1700. The drive spring release mechanism 1700 can include adrive spring 1702, a tension member 1704, a spring retainer 1706, and arelease cam 1708. The drive spring 102 can correspond to or representthe drive spring 1518 depicted, for example, in FIGS. 15 and 16. FIG. 17illustrates a cross-sectional view of the drive spring release mechanism1700. The drive spring release mechanism 1700 can be a component of thedrive mechanism 210 depicted in FIGS. 2 and 3.

FIG. 17 shows the drive spring release mechanism 1700 in a first stateor locked state with the drive spring 1702 in a compressed state. Thetension member 1704 and the spring retainer 1706 can prevent the drivespring 1702 from extending in a direction towards the tension member1704 relative to a positioning of the spring retainer 1706. The tensionmember 1704 can include a first arm or extension 1710 and a second armor extension 1712. The first and second extensions 1710 and 1712 canextend from a first end or base end of the tension member 1704 through acenter portion of the drive spring 1702. The first and second extensions1710 and 1712 can extend beyond an end of the drive spring 1702.

A first end 1720 of the first extension 1710 can be retained in place asshown by the spring retainer 1706. Similarly, a second end 1722 of thesecond extension 1712 can also be retained in place as shown by thespring retainer 1706. Specifically, the spring retainer 1706 can includea first portion 1714 positioned between the end of the drive spring 1702(e.g., a top or first end) and the end 1720 of the first extension 1710.Similarly, the spring retainer 1706 can include a second portion 1716positioned between the end of the drive spring 1702 (e.g., a bottom orsecond end) and the end 1722 of the second extensions 1712. The firstend 1720 and the second end 1722 can be considered to be lips ortraverse extensions of the first and second extensions 1710 and 1712,respectively.

The release cam 1708 can have a first portion 1718 positioned betweenthe first portion 1714 and the second portion 1716 of the springretainer 1706. The first portion 1714 of the spring retainer 1706 andthe first portion 1718 of the release cam 1708 can retain the end 1720of the first extension 1710 of the tension member 1704 as shown.Specifically, the first portion 1714 of the spring retainer 1706 and thefirst portion 1718 of the release cam 1708 can prevent the end 1720 ofthe first extension 1710 from moving away from the release cam 1708towards the drive spring 1702. Similarly, the second portion 1716 of thespring retainer 1706 and the first portion 1718 of the release cam 1708can prevent the end 1722 of the second extension 1712 from moving awayfrom the release cam 1708 towards the drive spring 1702. Accordingly,the first and second extensions 1710 and 1712 can be maintained adistance apart from each other so that the respective lips 1720 and 1722disposed on the extensions 1710 and 1712 interfere with the first andsecond portions 1714 and 1716, respectively.

The end 1720 of the first extension 1710 can be thicker or wider thanthe portion of the first extension 1710 that is positioned in a centeror middle of the drive spring 1702 (e.g., to form a lip or traverseextension as described above). As a result, the first portion 1714 ofthe spring retainer 1706 and the first portion 1718 of the release cam1708 can retain the first portion 1714 of the spring retainer 1706 asshown. Similarly, the end 1722 of the second extension 1712 can bethicker or wider than the portion of the second extension 1712 that ispositioned in a center or middle of the drive spring 1702 such that thesecond portion 1716 of the spring retainer 1706 and the first portion1718 of the release cam 1708 can retain the second portion 1712 of thespring retainer 1706. The drive spring release mechanism 1700 canmaintain the drive spring 1702 in a compressed or locked state as shownin FIG. 17 until activated—for example, by a patient input.

FIG. 18 illustrates the drive spring release mechanism 1700 in a secondstate or released state (also in cross-section). To release the drivespring 1702 so that it can expand, the release cam 1708 can be rotated.For example, the release cam 1708 can be rotated about an axis that isapproximately parallel and/or coaxial to an axis of the drive spring1702. The first portion 1718 of the release cam 1708 can have a variablewidth such that the first portion 1718 has a narrower width when therelease cam 1708 is rotated to release the drive spring 1702. As shownin FIG. 18, the narrow width or thickness of the first portion 1718 ofthe release cam 1708 allows the end 1720 of the first extension 1710 ofthe tension member 1704 to move away from the release cam 1708 towardthe second extension 1712 and under the first portion 1714 of the springretainer 1706. Similarly, the end 1722 of the second extension 1712 ofthe tension member 1704 is also allowed to move away from the releasecam 1708 toward the first extension 1710 and over the second portion1716 of the spring retainer 1706.

When the first extension 1710 of the tension member 1704 is able to moveunder the first portion 1714 of the spring retainer 1706 and the secondextension 1712 of the tension member 1704 is able to move over thesecond portion 1716 of the spring retainer 1706, the base portion of thetension member 1704 located on an end of the drive spring 1702 can nolonger maintain the drive spring 1702 in a compressed state.Accordingly, the drive spring 1702 is allowed to expand in a directionaway from the release cam 1708 as shown by a direction of movementindicator 1802. The tension member 1704 and the drive spring 1702 can beallowed to move in substantially the same direction away from therelease cam 1708. In various embodiments, the tension member 1704 can becoupled to the spheres 1520 illustrated in FIGS. 15 and 16. The movementof the tension member 1704 and the drive spring 1702 can apply a forceto the spheres 1520, thereby causing the plunger 1508 to advance intothe primary drug container 1502 to expel the liquid drug 1510.

In various embodiments, the release cam 1708 may be mechanicallyactuated. For example, the release cam 1708 can be mechanically actuatedby a patient applying a direct rotational force to the release cam 1708.In various other embodiments, the release cam 1708 can be mechanicallyactually by a patient by applying a rotational force indirectly—forexample, by a linkage. In various embodiments, the release cam 1708 maybe electromechanically actuated—for example, by a motor or any otherappropriate manner as will be appreciated by one of ordinary skill inthe art.

FIG. 19 illustrates an exemplary mechanism for accessing a liquid drugstored in a drug cartridge. In relation to the internal components ofthe drug delivery device 100 depicted in FIG. 16, FIG. 19 shows a firstview of the drug delivery device 100 and close-up view of theinteraction between the plunger 1508 and the primary drug container1502. The mechanism depicted in FIG. 19 can be used or included withinany of the drug delivery devices described herein.

As mentioned, the plunger 1508 can be pierceable. For example, theplunger 1508 can be pierceable by a hard needle 1902 coupled to theneedle conduit 1514. The hard needle 1902 can be coupled to an end ofthe needle conduit 1514. An initial force provide by the drive spring1518 when the drive spring 1518 is initially released can provide aforce to enable the hard needle 1902 to pierce the plunger 1508 andextend into the primary drug container 1502. The hard needle 1902 canextend into the primary drug container 1502 through an inlet or opening1904 formed when the hard needle 1902 is pressed against the plunger1508.

It will be appreciated that before the hard needle 1902 pierces theplunger 1508, the plunger 1508 may seal the primary drug container 1502to contain the liquid drug 1510. Further, prior to the plunger 1508being pierced, the plunger 1508 may seal the liquid drug 1510 off fromthe needle conduit 1514 (e.g., decouple or separate the liquid drug 1510from the needle conduit 1514) such that the liquid drug 1510 cannot besupplied to the patient.

The plunger 1508 can be designed to facilitate removal of the liquiddrug 1510 from the primary drug container 1502. For example, an end ofthe plunger 1508 that is adjacent to the portion of the primary drugcontainer 1502 that holds the liquid drug 1510 can include one or morechannels 1906. The channels 1906 can be arranged and positioned in anymanner. As shown in FIG. 19, the channels 1906 can form a cross-likepattern or shape. As the plunger 1508 is moved, the liquid drug 1510 canbe forced out of the primary drug container 1502 through the hard needle1902 and on to the needle conduit 1514. The channels 1906 can help forceor funnel the liquid drug 1510 towards the needle 1902 and needle inlet1904. As a result, more of the liquid drug 1510 can be expelled from theprimary drug container 1502 by reducing the amount of the liquid drug1510 trapped or retained inside of the primary drug container 1502.

As shown in FIG. 19, the needle 1902 and opening 1904 are positionedaway from a center of the plunger 1508. For example, the needle 1902 andopening 1904 are positioned towards an outer diameter of the spheres1520 and can be positioned outside of the guide coil 1602. In variousembodiments, the needle 1902 and opening 1904 can be positioned at ornear an approximate center of the plunger 1508 with the channels 1906arranged and positioned to guide the liquid drug toward the center ofthe plunger 1508.

FIG. 20 illustrates an exemplary alternative drive system 2000 fordelivering a liquid drug to a patient. The drive system 2000 can be usedwith any of the drug delivery devices described herein (e.g., the drugdelivery device 100). The drive system 2000 can be used to provide asingle dose of liquid drug to a patient over a specified amount of timeor multiple doses of the liquid drug to the patient. The drive system2000 can correspond to the drive mechanism 210 described in relation toFIGS. 2 and 3.

As shown in FIG. 20, the drive system 2000 can include springs 2002positioned between the spheres 1520. The springs 2002 can be consideredinterstitial springs or intermediate springs. The springs 2002 can becompressions springs or conical helical springs. As shown in FIG. 20,springs 2002 can be positioned between each sphere 1520. In variousembodiments, the drive system 2000 can include one or more springs 2002positioned between at least two adjacent spheres 1520. For example, thedrive system 2000 can include as few as a single spring 2002 positionedbetween two adjacent spheres 1520. When two or more springs 2002 areused, the springs 2002 can be considered in series.

The drive system 2000 can include a release mechanism—for example, agate or lynch pin—that can control advancement of the spheres 1520 andthe springs 2002 toward the plunger 1508. In various embodiments, a gateor lynch pin can be positioned between the plunger 1508 and the firstsphere 1520 positioned adjacent to the plunger 1508. The gate or lynchpin can prevent advancement of the spheres 1520 and can thereforeprevent a force from being applied to the plunger 1508. When the gate orlynch pin is removed, a force from the spheres 1520 and the springs 2002can be applied to the plunger 1508. Removal of the gate or lynch pin caninitiate activation of the drug delivery device incorporating the drivesystem 2000. Other release mechanism can include a spring releasemechanism that can restrict or allow movement (e.g., expansion) of oneor more of the springs 2002. For example, the drive system 2000 caninclude a release mechanism that can maintain the springs 2002 in acompressed state and can allow the springs 2002 to expand when desired.The springs 2002 can be released at substantially the same time (e.g.,to provide the liquid drug 1510 to the patient in a single dose).Alternatively, the springs 2002 can be released at different times(e.g., to provide the liquid drug 1510 to the patient over multipledoses).

In various embodiments, one or more the spheres 1520 of the drive system2000 can be directly touching or in contact with one another with aspring 2002 positioned between any adjacent touching spheres 1520. Thesprings 2002 can be of the same size or of different sizes. The springs2002 can each provide a same force or different forces when expanded. AsThe release mechanism of the drive system 2000 can allow the springs2002 to be released/expanded at substantially the same time or atdifferent times. For example, the springs 2002 can be releasedsequentially (or released in groups sequentially). In general, thesprings 2002 can be allowed to expand at desired times according to adesired dosing schedule.

A track or housing or other guide (not shown in FIG. 20 for simplicity)can surround or partial enclose or contain the spheres 1520 and thesprings 2002 to guide the movement of the spheres 1520 and the springs2002. The last sphere 1520 of the drive system 2000 (e.g., the sphere1520 positioned furthest from the plunger 1508) can be positionedagainst a solid element (not shown in FIG. 7) which can provide a pushpoint for the drive system 2002. Alternatively, an assistor spring canbe placed at the end of the depicted spheres 1520 and springs 2002. Invarious embodiments, the drive spring 1518 can be used as an assisterspring. An assistor spring can be used to provide additional force tothe plunger 1508. In various embodiments, an assistor spring can besimilar to the previously mentioned drive spring 1518. For example, anassistor spring can be similar to the drive spring 1518 but may have alower spring constant, k, since the springs 2002 can each provide acomponent of the overall provided driving force. The assistor spring canbe a coil spring, an elastomeric element, or any other appropriatedevice (e.g., one or more compression springs arranged in any manner orconfiguration) for providing a desired actuation assisting force to thespheres 1520. Further, the springs 2002 can be arranges in series, whichcan result in a lower total or equivalent spring constant that canprovide a more even force over time as the springs 2002 expand.

The drive system 2000 can provide tunability for adjusting how quicklythe liquid drug of the primary drug container 1502 can be expelled. Forexample, the springs 2002 can be added or removed to speed up or slowdown the rate of drug delivery, respectively, for a given liquid drug.More springs 2002 may be used for liquid drugs having a relativelyhigher viscosity while fewer springs 2002 may be used for liquid drugshaving a relatively lower viscosity. Further, more springs 2002 can beused to increase a stroke of the plunger 1508. The introduction of thesprings 2002 can provide a more constant force over time and distancesuch that the liquid drug 1510 can be delivered at a more constant ratethroughout the delivery of the drug (e.g., as compared to drive systemarrangements employing only a single drive spring). Further, each spring2002 can be tailored to provide a desired spring constant and/or desiredamount of force.

The drive system 2000 can provide an approximately constant spring force(e.g., a change of less than 5% of force over a stroke). By using alarge number of springs 2002, the force provided by the series coupledsprings 2002 can be largely constant, thereby ensuring precise drugdelivery over a long period of time. The drive system 2000 is also spaceefficient as the air space between the spheres is largely consumed.Again, the drive system 2000 provides an easily tunable load (e.g., toprovide a variable drive force). Specifically, the load pushing on theplunger 1508 can be adjusted by adding or removing springs 2002 betweenthe spheres 1520. This can allow for tuning of the delivery rate fordrugs of different viscosities without needing to change the base designor introduce new parts. Differently sized primary drug containers 1502(e.g., cartridges of different lengths) can also be accommodated byadding or removing springs 2002 and spheres 1520. Any of the drivesystems described herein can include one or more intermediate springs2002. For example, the drive systems depicted in FIGS. 15 and 16 can bemodified to include one or more springs 2002 as shown in FIG. 20.

FIG. 21 illustrates an exemplary alternative drive system 2100 fordelivering a liquid drug to a patient. The drive system 2100 can be usedwith any of the drug delivery devices described herein (e.g., the drugdelivery device 100). The drive system 2100 can be used to advance themovement of spheres 1520 as desired to provide delivery of the liquiddrug 1510 over multiple doses. The drive system 2100 can correspond tothe drive mechanism 210 described in relation to FIGS. 2 and 3. Thedrive system can include any or all features of the drive systemsdescribed in relation to FIGS. 15, 16 and/or 20.

As shown in FIG. 21, the drive system 2100 can include a gate 2102. Thegate 2102 can be positioned in front of the primary drug container 1502.The gate 2102 can be controlled to regulate the advancement of thespheres 1520 and application of a force against the plunger 1508. Byregulating the advancement of the spheres 1520, the drive system 2100can be considered as providing a metered ball or sphere drive system.

FIG. 21 shows the drive system 2100 in an initial or first state.Specifically, the gate 2102 is positioned between the first sphere 1520and the primary drug container 1502. The spheres 1520 cannot advancefurther toward the plunger 1508. As result, the liquid drug 1510 is notexpelled from the primary drug container 1502. As described herein, thegate 2102 can move in the directions 2104 to allow advancement of thespheres 1520 and to prevent advancement of the spheres 1520. As shown inFIG. 22, the primary drug container access mechanism 1512 can bepositioned adjacent to the plunger 1508. One or more individualcomponents of the primary drug container access mechanism 1512 are notshown in FIG. 21 for simplicity. In various embodiments, the spheres1520 can advance the plunger 1508 by applying a force to the primarydrug container access mechanism 1512, which, in turn, can apply theforce to the plunger 1508. In various other embodiments, for examplewhen the needle conduit 1514 is coupled to a septum end of the primarydrug container 1502, the spheres 1520 can directly apply a force on theplunger 1508 (e.g., the primary drug container access mechanism 1512 canbe removed).

FIG. 22 illustrates the drive system 2100 in a second or subsequentstate of operation. Specifically, FIG. 22 shows the gate 2102 in an openstate. When in an open state, the gate 2102 no longer interrupts theadvancement of the spheres 1520. That is, the gate 2102 is moved to adifferent position positon that does not block the spheres 1520 fromadvancing toward the plunger 1508. As a result, the spheres 1520 canapply a force on the plunger 1508 to advance it forward, therebyexpelling the liquid drug 1510 from the primary drug container 1502.

As shown in FIG. 22, a first sphere 2202 has advanced past the gate 2102toward the plunger 1508. Consequently, the plunger 1508 has beenadvanced by an amount or distance 2204 relative to a starting point ofthe plunger 1508 as shown in FIG. 21. The amount 2204 that the plunger1508 has advanced can correspond to approximately a diameter of thefirst sphere 2202. The diameter of the first sphere 2202 (as well as thediameters of all the spheres 1520) can correspond to one stroke ofdelivery of the liquid drug 1510. That is, for each sphere 1520 thatadvances past the gate 2102, an amount of the liquid drug 1510corresponding to a size of each of the spheres 1520 (e.g., a diameter ofthe spheres 1520) can be pushed out from the primary drug container1502. As further shown in FIG. 22, the drive spring 1518 can expand toapply the force to the spheres 1520, driving the spheres 1520 toward theplunger 1508.

By regulating the number of spheres 1520 that can advance past the gate2102, the gate 2102 can control the amount of the liquid drug 1510provided to the patient. Each time the gate 2102 is placed into an openposition as shown in FIG. 22, one or more spheres 1520 can advance pastthe gate 2102. The number of spheres 1520 that advance past the gate2102 can determine the amount of the liquid drug 1520 provided to thepatient. The gate 2102 can allow the same number of spheres 1520 toadvance each time the gate 2102 is opened or can allow different numbersof spheres 1520 to advance. When the gate 2102 is controlled to allowthe same number of spheres 1520 to advance, then the drive system 2100can provide multiple doses of approximately the same amount or volume ofthe liquid drug 1510 to the patient. When the gate is controlled toallow different numbers of spheres 1520 to advance, then the drivesystem 2100 can provide multiple doses of different amounts or volumesof the liquid drug 1510 to the patient. The gate 2102 can be controlledby a mechanical or electromechanical mechanism and can be automaticallycontrolled or patient controlled. Overall, the gate 2102 can becontrolled to provide a single dose to the patient or multiple doses tothe patient at any desired time over any desired amount of time.

FIG. 23 illustrates the drive system 2100 in a third or subsequent stateof operation. As shown in FIG. 23, the gate 2102 is in a closed positionand the first sphere 2202 is positioned between the gate 2102 and theplunger 1508. With the gate 2102 in the closed position, the gate 2102can impede further advancement of the remaining spheres 1520. As aresult, a dose of the liquid drug 1510 corresponding the diameter of thefirst sphere 2202 has been provided to the patient.

Overall, regulating the location or position of the gate 2102 can inturn regulate delivery of the liquid drug 1510 to a patient. A desireddosage of the liquid drug 1510 can be delivered to a patient over adesired amount of time in this manner.

FIG. 24 illustrate an exemplary gate control mechanism 2400. The gatecontrol mechanism 2400 can be used to control operation and movement ofthe gate 2102. As shown in FIG. 24, the gate control mechanism 2400 caninclude a gate 2402, a gate actuator 2404, a patient control component2406, and a controller 2408. The gate 2402 can correspond to the gate2102. The gate actuator 2404 can be any device capable of moving thegate 2402 between at least a first positon (e.g., a closed positon asdescribed in relation to FIG. 23) and a second position (e.g., an openpositioning as described in relation to FIG. 23) responsive to thepatient control component 2406 or the controller 2408. In variousembodiments, the gate actuator 2404 can be a ratchet, a lever, a spring,or a gear. In various embodiments, the gate actuator 2404 can include amotor and an arm or other component to move the gate 2402. In variousembodiments, the gate actuator 2404 can operate mechanically orelectromechanically to adjust the positioning of the gate 2402.

The patient control component 2406 can be any component or feature forreceiving input from a patient. In various embodiments, the patientcontrol component 2406 can include one or more buttons or switches. Thepatient control component 2406 can be used to specify when the gate 2402is to be in an open positon or a closed position. The gate actuator 2404can be responsive to the patient control component 2406 such that thegate 2402 opens and closes responsive to a patient. The patient controlcomponent 2406 can correspond to any of the patient interaction elementsor components described herein (e.g., the patient interaction component108 of the drug delivery device 100).

The controller 2408 can be used to automatically control operation ofthe gate 2402. In various embodiments, the controller 2408 can alsocontrol operation of the gate 2402 based on input from the patientcontrol component 2406. The controller 2408 can correspond to thecontroller 302 described in relation to FIG. 3. The gate actuator 2404can be responsive to controller 2408 such that the gate 2402 opens andcloses responsive to the controller 2408. The controller 2408 can beprogrammed or otherwise instructed to regulate operation of the gate2402 to provide multiple doses of a liquid drug to a patient asdescribed in relation to FIG. 23.

FIG. 25 illustrates a fourth exemplary embodiment of a drug deliverydevice 2500. The drug delivery device 2500 can operate and providesubstantially the same functionality as the drug device 100, the drugdelivery device 900, and/or the drug delivery device 1400. As shown inFIG. 25, the drug delivery device 2500 can include a top portion 2502and a bottom portion 2504. The top portion 2502 and the bottom portion2504 can together form a housing of the drug delivery device 2500. Thetop portion 2502 and the bottom portion 2504 can be coupled together toform an outside of the drug delivery device 2500. The drug deliverydevice 2500 can represent another design or form factor of the drugdelivery device 100, the drug delivery device 900, and/or the drugdelivery device 1400.

As further shown in FIG. 25, the drug delivery device 2500 can include afirst patient interaction element or component 2506 and a second patientinteraction element or component 2508. The first and second patientinteraction elements 2506 and 2508 can each be buttons located onopposite sides of the drug delivery device 2500. The buttons 2506 and2508 can be used to activate and/or operate the drug delivery device2500.

FIG. 26 illustrates a top view of the drug delivery device 2500. Asshown in FIG. 26, the first and second buttons 2506 and 2508 arepositioned on opposite sides of the drug delivery device 2500.

FIG. 27 illustrates an activation mechanism of the drug delivery device2500. The activation mechanism of the drug delivery device 2500 can bebased on operation of the first and second buttons 2506 and 2508. Thedepicted activation mechanism can be included or used with any of thedrug delivery devices described herein. In various embodiments, theactivation mechanism of FIG. 27 may provide a “double lockout” featurethat can prevent inadvertent or premature activation of the drugdelivery device 2500. For example, the drug delivery device 2500 may notdeliver a liquid drug to the patient until both the first and secondbuttons 2506 and 2508 have been activated, either in series orsimultaneously, as will be described herein. As shown in FIG. 27, afirst sphere 2702 is positioned adjacent to the primary drug container1502. The first sphere 2702 is blocked from advancing toward the primarydrug container 1502 by a first ball 2704 and a set of balls 2706. Thefirst ball 2704 can be positioned on a first side of the first sphere2702 and the set of balls 2706 can be positioned on a second, oppositeside of the first sphere 2702. The set of balls 2706 can include anynumber of balls. The set of balls 2706 can be positioned on a track ortray 2708 that guides the movement of the balls 2706. In variousembodiments, two or more balls can be used in place of the single firstball 2704. In various embodiments, as an alternative to the set of balls2706, a rod can be used. The rod can have a length that is approximatelythe same as the length of the set of balls 2706 together. The rod canhave rounded ends.

The first sphere 2702, and the remaining spheres 1520, can be allowed toadvance toward the primary drug container 1502 when the first ball 2704and the set of balls 2706 are moved away from the first sphere 2702.Movement of the first ball 2704 can be determined based on operation ofthe second button 2508. Movement of the set of balls 2706 can bedetermined based on operation of the first button 2506. In variousembodiments, the movement of the first ball 2704 can be determined basedon operation of the first button 2506 and movement of the set of balls2706 can be determined based on operation of the second button 2508.

As mentioned, the set of balls 2706 may be coupled indirectly to thefirst button 2506. Movement of the set of balls 2706 can be restrictedby an arm 2710. The arm 2710 can be positioned across the track 2708 torestrict or prevent movement of the set of balls 2706 along the trackaway from the first sphere 2702. Movement of the arm 2710 can becontrolled by the first button 2506. Specifically, when the button 2506is engaged, a pin 2712 coupled to the button 2506 can be moved in adirection (e.g., downwards and/or sideways) through an opening 2714 inthe arm 2710. When the pin 2712 is moved through the opening 2714, thearm 2710 can be released, and thereby allowed to move in a direction2716 away from the set of balls 2706, as shown in FIG. 27. A spring 2718can assist the movement of the arm 2710 in the direction 2716 when thearm 2710 is released. Prior to pressing on the button 2506, the pin 2712can restrict movement of the arm 2710 in the direction 2716, therebymaintaining the set of balls 2706 in the position shown in FIG. 27. Thearm 2710 can be referred to as a sliding link.

Movement of the arm 2710 in the direction 2716 can allow the set ofballs 2706 to move in a direction 2726 (e.g., away from the first sphere2702). The set of balls 2706 can move in the direction 2726 along thetrack 2708. After moving along the track 2708, the set of balls 2706 canbe positioned away from the first sphere 2702 and can no longer restrictmovement of the spheres 1502. In various embodiments, upon release, theset of balls 2706 may naturally move along the track 2708 (e.g., underthe force of gravity), or they may be forced to move along the track2708 in the direction 2726 due to the force of the sphere 2702.

The second button 2508 may be indirectly coupled to the first ball 2704.Movement of the first ball 2704 can be restricted by a latch 2720. Thelatch 2720 can be positioned to restrict movement of the first ball 2704in a direction 2722. Movement of the first ball 2704 can be controlledby the second button 2508. Specifically, when the button 2508 is engaged(e.g., moved laterally to slide along an outer surface of the drugdelivery device 100), the latch 2720 can move in a direction that allowsthe first ball 2704 to move in the direction 2722 and away from thefirst sphere 2702. For example, the button 2508 can be slid in adirection 2724, which can cause the latch 2720 to also move in thedirection 2724, thereby enabling the first ball 2704 to move away fromthe first sphere 2702 in the direction 2722. When the first ball 2704moves in the direction 2722, the first ball 2704 can also no longer bepositioned in front of the first sphere 2702. Consequently, the firstball 2704 can no longer restrict movement of the spheres 1520. Thespheres 1520 can therefore be allowed to advance toward the primary drugcontainer 1502 to initiate delivery of a stored liquid drug to apatient. The latch 2720 can be referred to as a push-pull rod.

The buttons 2506 and 2508 can be operated in conjunction to activate thedrug delivery device 2500. In various embodiments, the buttons 2506 and2508 can activate the drug delivery device 2500 by being manipulated atsubstantially the same time or in a predefined order (e.g., the button2506 is manipulated first and the second button 2508 is manipulatedsubsequently). Once the buttons 2506 and 2508 are engaged, the spheres1520 can be allowed to apply a force on the plunger 2508 to expel anyliquid drug stored in the primary drug container 1502. The liquid drugcan then be provided to the patient in a single dose for example.

FIG. 28 illustrates a cross-sectional view of a portion of the drugdelivery device 2500 shown in FIG. 27. FIG. 28 further shows how thedrug delivery device 2500 can be activated. As shown in FIG. 28,movement of the set of balls 2706 along the guide 2708 can be restrictedby the arm 2710. When the arm 2710 is moved in the direction 2716, thearm 2710 can removed from covering the guide 2708. As a result, the setof balls 2706 can be allowed to move in the direction 2718 along theguide 2708, thereby no longer blocking movement of the spheres 1520 fromadvancing along a direction 2802 as shown.

As further shown in FIG. 28, the latch 2720 can prevent the first ball2704 from moving in the direction 2722. When the latch 2720 is moved inthe direction 2724, the latch can be removed from restricting movementof the first ball 2704. As a result, the first ball 2704 can be allowedto move in the direction 2722, thereby no longer blocking movement ofthe spheres 1520 from advancing in the direction 2802.

After the first ball 2704 and the set of balls 2706 are removed from infront of the spheres 1520, the spheres 1520 can advance toward theprimary drug container 1502 (not shown in FIG. 28). As mentioned, thebuttons 2506 and 2508 can be operated at approximately the same time orin succession (e.g., in any order) to activate the drug delivery device.

In various embodiments, the latch 2720 can include a hole or openingthrough which the first ball 2704 can be forced through by the spheres1520. The opening of the latch 2720 can be positioned adjacent to thefirst ball 2704 when the latch is moved by the button 2508. Prior tomanipulation of the button 2508, the opening can be positioned so as notto be adjacent to the first ball 2704. When the opening of the latch2720 is positioned next to the first ball 2704, the movement of thespheres 1520 in the direction 2802 can cause the first ball 2704 throughthe opening and away from the spheres 1520. Some movement of the spheres1520 in the direction 2802 can be allowed after the set of balls 2706are removed from being positioned in front of the spheres 1520, allowinga force of the spheres 1520 to squeeze the first ball 2704 through theopening of the latch 2720.

In various embodiments, the activation mechanism depicted in FIGS. 27and 28 can be part of a drive mechanism or drug container accessmechanism of a drug delivery device described herein (e.g.,corresponding to a portion of the drive mechanism 210 and/or a portionof the primary drug container access mechanism 204 described in relationto FIGS. 2 and 3).

FIG. 29 illustrates an exemplary implementation of a primary drugcontainer access mechanism or component 2900. The primary drug containeraccess mechanism 2900 can be an implementation of the primary drugcontainer access mechanism 1512 depicted in FIG. 15. The primary drugcontainer access mechanism 2900 can be used with any of the drugdelivery devices described herein. FIG. 29 depicts the primary drugcontainer access mechanism 2900 relative to a cross section of the drugdelivery device 100 for purposes of describing the components andoperation of the primary drug container access mechanism 2900. Theprimary drug container access mechanism 2900 can correspond to theprimary drug container access mechanism 204 described in relation toFIGS. 2 and 3

As shown in FIG. 29, the primary drug container access mechanism 2900can include a needle pilot element or component 2902, a spacer spring2904, and a pusher plate element or component 2906. The needle pilotcomponent 2902 and the pusher plate component 2906 can be made of metalor plastic. The spacer spring 2904 can be a metal compression spring2904. The needle pilot component 2902, the spacer spring 2904, and thepusher plate component 2906 can operate to provide access to the primarydrug container 1502 through the plunger 1508.

As shown in FIG. 29, the needle pilot component 2902, the spacer spring2904, and the pusher plate component 2906 can be positioned between theplunger 1508 and a first sphere 1520. Specifically, the needle pilotcomponent 2902 can be positioned adjacent to the plunger 1508 and thepusher plate component 2906 can be positioned adjacent to the sphere1520. A side of the pusher plate component 2906 facing the sphere 1520can have a curvature approximately matching a curvature of the sphere1520, although such curvature is not critical and this surface of thepusher plate component 2906 could be flat or have another aligningfeature. In one non-limiting exemplary embodiment, the plunger 1508, theneedle pilot component 2902, the spacer spring 2904, and the pusherplate component 2906 can be positioned within the primary drug container1502.

In an initial or pre-activation state, the needle pilot component 2902can be spaced apart from the pusher plate component 2906 by a distance2908. The pusher plate component 2906 can also be spaced apart from thefirst sphere 1520. The spacer spring 2904 can be positioned within aninternal opening formed between the needle pilot component 2902 and thepusher plate component 2906. The needle conduit 1514 can be routed overa top of the sphere 1520 and into the pusher plate component 2906. Thepusher plate component 2906 can include an opening for the needleconduit 1514. Specifically, the needle conduit 1514 can be routedapproximately vertically through the pusher plate component 2906 andthen routed approximately horizontally through the pusher platecomponent 2906 in an approximate center of the pusher plate component2906. Other routings of the needle conduit 1514 through the pusher platecomponent 2906 are possible. That is, the needle conduit 1514 can berouted in any manner through the pusher plate component 2906. The needleconduit 1514 can then further extend across the distance 2908 separatingthe needle pilot component 2902 and the pusher plate component 2906.Further, the needle conduit 1514 can be routed through a center of thespacer spring 2904 and through an approximate center of the needle pilotcomponent 2902 as shown.

While in the initial state, the needle conduit 1514 can be positionedthrough a portion of the plunger 1508 but does not make contact with theliquid drug 1510. When positioned through a portion of the plunger 1508,the needle conduit 1514 can be considered to be partially embeddedwithin the plunger 1508. In various other embodiments, the needleconduit 1514 can be initially positioned outside of the plunger 1508(e.g., adjacent to the plunger 1508). When positioned outside oradjacent the plunger 1508, the needle conduit 1514 can be considered tobe fully separated from the plunger 1508. The primary drug containeraccess mechanism 2900 can be used to advance an end of the needleconduit 1514 fully through the plunger 1508 when activated with theneedle conduit 1514 either initially partially embedded within theplunger 1508 or fully separated from the plunger 1508 as describedherein.

During this initial, pre-activation state, the sphere 1520 can berestricted from moving forward in a direction 2910 (and/or no force canbe applied to the sphere 1520). Subsequent to the initial state, whenthe drug delivery device of which the primary drug container accessmechanism 2900 can be a part is activated, the sphere 1520 can beallowed to move in the direction 2910 toward the pusher plate component2906. When the sphere 1520 makes contact with the pusher plate component2906, the force from the sphere 1520 can cause the pusher platecomponent 2906 to move forward toward the plunger 1508.

The pusher plate component 2906 can cause the spacer spring 2904 tocompress and the pusher plate component 2906 can make contact with theneedle pilot component 2902, moving the needle pilot component 2902toward the plunger 1508. As a result of the movement of the sphere 1520,the pusher plate component 2906, and the needle pilot 2902 toward theplunger, a needle 2912 or end component of the needle conduit 1514 canbe pushed through the plunger 1508 into the liquid drug 1510. Overall,the end of the needle conduit 1514 (which can include the needle 2912),can be driven forward through the plunger 1508, thereby coupling theneedle conduit 1514 to the liquid drug 1510.

The needle pilot component 2902 can help maintain the needle conduit1514 centered along the plunger 1508 to facilitate efficient removal ofthe liquid drug 1510. The spacer spring 2904 can keep the needle pilotcomponent 2902 and the pusher plate component 2906 separated and taughtprior to activation/insertion of the tip 2912 of the needle conduit 1514into the liquid drug 1510. The pusher plate component 2906, the spacerspring 2904, and the needle pilot component 2904 can all move in adirection 2914 to push the plunger 1508 in the direction 2914 to expelthe liquid drug 1510 through the needle conduit 1514 as the spheres 1520push on the pusher plate component 2906.

FIG. 30 illustrates an exemplary alternative drive system 3000 fordelivering a liquid drug to a patient. The drive system 3000 can be usedwith any of the drug delivery devices described herein (e.g., the drugdelivery device 100). The drive system 3000 can be used to advance themovement of spheres 1520 as desired to provide delivery of the liquiddrug 1510 over multiple doses. The drive system 3000 can correspond tothe drive mechanism 210 described in relation to FIGS. 2 and 3. Thedrive system 3000 can include any feature of any of the other drivesystems described herein.

As shown in FIG. 30, the drive system 3000 can include a first wheel orroller 3002 and a second wheel or roller 3004. The rollers 3002 and 3004can be positioned above the path of the spheres 1520. The rollers 3002and 3004 can regulate forward movement of the needle conduit 1514 towardthe plunger 1508. A portion of the needle conduit 1514 can be routedbetween the rollers 3002 and 3004. An end portion of the needle conduit1514 can include a hard needle 3006. The hard needle area 3006 can beadvanced forward by the force of the spheres 1520. The rollers 3002 and3004 can function as a brake or as a metering system for regulating theamount of the needle conduit 1514 that can be moved toward the plunger1508. Specifically, the rollers 3002 and 3004 can determine when theplunger 1508 can be advanced by allowing or preventing the needleconduit 1514—and in turn the hard needle area 3006—from moving forward(e.g., as a result of the force applied by the drive spring 1518).

A portion of the needle conduit 1514 can form a coil 3008. The coil 3008of the needle conduit 1514 can be held in place so that it can be paidout for translation to the rollers 3002 and 3004. A back portion 3010 ofthe needle conduit 1514 can form a loop or be otherwise shaped toprovide a service loop for the needle insertion mechanism 1516.

In the drive system 3000, the needle conduit 1514 can be used as atension member that is allowed to advance past the rollers 3002 and 3004toward the plunger 1508 to enable the spring force form the drive spring1518 to be applied to the plunger 1508 through the spheres 1520.Accordingly, the needle conduit 1514 can hold the drive spring 1518 backto control application of the force from the drive spring 1518 to theplunger 1508 as the spheres 1520 can be arranged to apply a force to thehard needle area 3006 of the needle conduit 1514.

The rollers 3002 and 3004 can be considered to be a clutch thatregulates movement of the plunger 1508 and can therefore meter outadvancement of the needle conduit 1514 and the spheres 1520, therebyallowing the drive system 3000 to be controlled for delivery of theliquid drug 1510 over multiple doses. The rollers 3002 and 3004 can bemechanically and/or electromechanically controlled. By incrementallyallowing the rollers 3002 and 3004 to move or turn, incremental doses ofthe liquid drug 1510 to the patient. The drive system 3000 can providefor any incremental advancement of the plunger 1508. For example, theplunger 1508 can be advanced by an amount equal to less than thediameter of the spheres 1520, allowing for fine control of the amount ofthe liquid drug 1510 delivered to the patient. As the rollers 3002 and3004 operate to start and stop advancement of the needle conduit 1514and therefore the spheres 1520 and plunger 1508, the drive system 3000can be considered to be a clutched needle drive system.

FIG. 31 illustrates an exemplary alternative drive system 3100 fordelivering a liquid drug to a patient. The drive system 3100 can be usedwith any of the drug delivery devices described herein (e.g., the drugdelivery device 100). The drive system 3100 can be used to advance themovement of spheres 1520 as desired to provide delivery of the liquiddrug 1510 over multiple doses. The drive system 3100 can correspond tothe drive mechanism 210 described in relation to FIGS. 2 and 3. Thedrive system 3100 can include any feature of any of the other drivesystems described herein.

As shown in FIG. 31, the drive system 3100 can include a dosing wheel3102. The dosing wheel 3102 can include a number of arms or spokes 3104that radially extend from a hub. The dosing wheel 3012 can have anynumber of arms 3104. One or more of the arms 3104 can be positionedbetween adjacent spheres 1520. The dosing wheel 3102 can rotate in adirection 3106 as shown about an axis of the dosing wheel 3102 to movethe spheres 1520 forward toward the primary drug container 1502. Thedrive spring 1518 can provide the force to move the spheres 1520 asregulated by the dosing wheel 3102. That is, the dosing wheel 3102 canimpede forward movement of the spheres 1520 until the dosing wheel 3102rotates a desired amount in the direction 3106.

The dosing wheel 3102 can be controlled to rotate any desired amount.The dosing wheel 3102 can be triggered to rotate using a ratchet with arelease that allows the dosing wheel 3102 to rotate a certain amount(e.g., a number of degrees) before re-engaging and stopping. The dosingwheel 3102 can allow less than a full sphere 1520 to advance toward theplunger 1508. That is, since the dosing wheel 3102 can rotate anydesired amount, any portion of a width of one of the spheres 1520 can beallowed to advance, enabling precise multiple dose control of the liquiddrug 1510. In general, an amount of rotation of the dosing wheel 3102can determine or correspond to an amount of the liquid drug 1510expelled from the primary drug container 1502.

As further shown in FIG. 31, the drive system 3100 can be coupled to acontroller and/or patient interaction component 3108. The dosing wheel3102 can be controlled to rotate responsive to the controller 3108.Alternatively, the patient interaction component 3108 can include afeature enabling a patient to determine when the dosing wheel 3102rotates. For example, the patient interaction component 3108 can includea button that a patient can press to advance the dosing wheel 3102 by afixed amount.

In various embodiments, the arms 3104 can be flexing arms or flexiblearms allowing the arms 3104 to fold out of the way when passing theprimary drug container 1502. Further, as the arms 3104 rotate, the arms3104 can engage a next sphere 1520 being pushed forward by the drivespring 1518. In various embodiments, the arms 3104 can include a hingeto enable the arms 3104 to fold or bend about the hinge such that thearms 3104 can be folded to prevent interference with the primary drugcontainer 1502. The

FIG. 32 illustrates an exemplary alternative drive system 3200 fordelivering a liquid drug to a patient. The drive system 3200 can be usedwith any of the drug delivery devices described herein (e.g., the drugdelivery device 100). The drive system 3200 can be used to advance themovement of spheres 1520 as desired to provide delivery of the liquiddrug 1510 over multiple doses. The drive system 3200 can correspond tothe drive mechanism 210 described in relation to FIGS. 2 and 3. Thedrive system 3200 can include any feature of any of the other drivesystems described herein.

As shown in FIG. 32, the drive system 3200 can include a rotatable arm3202. The rotatable arm 3202 can be controlled to apply a force to thespheres 1520 which can translate the force to the plunger 1508. Thedrive system 3200 can be implemented without a drive spring (e.g., thedrive spring 1518 as described in relation to FIG. 15). The rotatablearm 3202 can rotate about a point or axis 3404.

The rotatable arm 3202 can be controlled mechanically orelectromechanically. The rotatable arm 3202 can be controlled to rotateany amount relative to an axis 3404, thereby providing the ability toprovide the liquid drug 1520 to the patient over multiple doses. Therotatable arm 3210 can be part of a transmission or gear reductiontransmission for delivering the drug contained in the container 3202. Asshown in FIG. 32, the rotatable arm 3202 can rotate in a clockwisemanner to move the spheres 1520 against the plunger 1508.

Movement of the rotatable arm 3202 can be actuated by a power sourcesuch as a motor (e.g., an electrical motor). Various mechanical,electrical, and/or electromechanical mechanisms can be used to rotate ormove the rotatable arm 3202. As examples, a constant force spring, atorsion spring, or a spiral torsional spring can be used to provide aforce that causes the rotatable arm 3202 to move. The use of a constantforce spring may be particularly advantageous as a constant force springmay not decay in the same manner as a linear spring.

The mechanism for moving the rotatable arm 3202 can allow for multipledoses of a drug to be delivered. That is, the mechanism for moving therotatable arm 3210 can be used to deliver a dose, then stop delivery,and then restart delivery as desired (e.g., based on a desired deliveryschedule in terms of dosage amount and delivery times). The mechanismfor moving the rotatable arm 3210 can provide a compact movementmechanism, lending itself to inclusion in a small space within awearable drug delivery device. Further, the mechanism can include one ormore gears and/or can include one or more reduction mechanisms to adjustthe efficiency of the mechanism for moving the rotatable arm 3202. Canalso dose any amount, less than that corresponding to sphere.

FIG. 39 illustrates an exemplary alternative drive system 3900 fordelivering a liquid drug to a patient. The drive system 3900 can be usedwith any of the drug delivery devices described herein (e.g., the drugdelivery device 100). The drive system 3900 can be used to advance themovement of spheres 1520 as desired to provide delivery of the liquiddrug 1510 over multiple doses. The drive system 3900 can correspond tothe drive mechanism 210 described in relation to FIGS. 2 and 3. Thedrive system 3900 can represent a particular implementation of the drivesystem 3200 depicted in FIG. 32. The drive system 3900 can include anyfeature of any of the other drive systems described herein.

FIG. 39 shows a top or overhead view of the drive system 3900. The drivesystem 3900 can include any of the features and components of the drivesystems and/or drug delivery devices described herein. Many features ofthe drive system 3900 such as, for example, a plunger, a sphere track,and a needle conduit are not shown in FIG. 39 for simplicity.

As shown in FIG. 39, the drive system 3900 can include a torsion spring3902. The torsion spring 3902 can be coiled as shown to include anextending arm 3904. The arm 3904 can be positioned behind a set ofspheres 1520. The torsion spring 3902 can be centered about an axis orcenter point 3906. The axis or center 3906 can be approximatelypositioned in a center of the torsion spring 3902. In variousembodiments, the torsion spring 3902 can be a double-bodied torsionspring.

In an initial state, the torsion spring 3902 can be held or maintainedin a coiled or compressed state. After activation, the torsion spring3902 can be released and allowed to uncoil or expand. During release,the arm 3904 can rotate (e.g., in a clockwise direction) to advance thespheres 1520 toward the primary drug container 1502. In variousembodiments, the center 3906 of the torsion spring 3902 can be offsetfrom a center of a sphere track radius, which can improve angles ofincidence for more efficient energy transfer from the torsion spring3902 to the spheres 1520. The torsion spring 3902 can rotate about thecenter point 3906. In various embodiments, the tines or tongue of thetorsion spring 3902 (e.g., as a double-bodied torsion spring) can beused to advance the spheres 1520.

As shown in FIG. 39, the torsion spring 3902 can be positioned adjacentto a track 3908. The track 3908 can correspond to or be animplementation of the track 1524 and/or the track 3802. The track 3908can guide the spheres 1520 toward the plunger 1508. The track caninclude an open section or cutout to allow the arm 3904 to move insideof the track 3908 to advance the spheres 1520.

The arm 3904 can be retained by to activation by a number of mechanismsuch as, for example, a pin, rod, or other mechanical component. Onceactivated, the arm 3904 can be allowed to rotate (e.g., in a clockwisedirection relative to FIG. 39). An inhibitor component 3910 can be usedto prevent rotation and/or movement of the other portion of the torsionspring 3910. The inhibitor component 3910 can be a mechanical devicesuch as, for example, a pin or rod restricting movement of the torsionspring 3902.

FIG. 40 illustrates a side view of the drive system 3900 depicted inFIG. 39. As shown, the torsion spring 3902 can be positioned adjacent tothe primary drug container 1502 to allow the arm 3904 to make contactwith the spheres 1520. FIG. 40 shows the axis or center 3906 of thetorsion spring 3902 about which the arm 3904 can rotate. The drivesystem 3900 can occupy less area than other drive systems describedherein, enabling a drug delivery device that includes the drive system3900 to be provided in a smaller form factor or size.

FIG. 33 illustrates an exemplary alternative drive system 3300 fordelivering a liquid drug to a patient. The drive system 3300 can be usedwith any of the drug delivery devices described herein (e.g., the drugdelivery device 100). The drive system 3300 can be used to advance themovement of the plunger 1508 as desired to provide delivery of theliquid drug 1510 over multiple doses. The drive system 3300 cancorrespond to the drive mechanism 210 described in relation to FIGS. 2and 3. The drive system 3300 can include any feature of any of the otherdrive systems described herein.

As shown in FIG. 33, the drive system 3300 can include a flexible driveelement 3302 and a rotatable nut 3304. The flexible drive element 3302can be a helical compression spring (e.g., a flexible lead screw). Theflexible drive 3302 can be coupled to the rotatable nut 3304. Therotatable nut 3304 can be positioned at an end of the primary drugcontainer 1502. The flexible drive element 3302 can be coupled to therotatable nut 3304. For example, the flexible drive element 3304 canpass through a center of the rotatable nut 3304. The rotatable nut 3304can remain in a fixed positioned, coupled to the end 1506 of the primarydrug container 1502.

The rotatable nut 3304 can drive movement of the flexible drive element3302. That is, the rotatable nut 3302 can include threads coupled to theflexible drive element 3302 to enable movement of the flexible driveelement 3302 based on movement of the rotatable nut 3304. For example,rotating the rotatable nut 3304 in a first direction 3306 can move theflexible drive element 3302 in a direction toward the plunger 1508.Rotating the rotatable nut 3304 in a second, opposite direction can movethe flexible drive element 3302 away from the plunger 1508. Therotatable nut 3304 can rotate perpendicularly to a vertical axispositioned in approximately a center of the primary drug container 1502.The flexible drive element 3302 can be arranged to pass through therotatable nut 3304 to contact the plunger 1508.

The rotatable nut 3304 can be controlled mechanically orelectromechanically. In various embodiments, the rotatable nut 3304 canbe driven by a gear system or other mechanism such as, for example, aspring or motor. The drive system 3300 enables a force to be applied tothe plunger 1508 in a tight and compact space without using a drivespring or spheres. The drive system 3300 can operate without applyingany force to the flexible drive element 3302 behind the rotatable nut3304. The flexible drive element 3302 can be routed as desired within adrug delivery device. In various embodiments, the flexible drive element3302 can be a round wire or a rectangular wire. The rotatable nut 3304can be controlled such that its rotation can cause the flexible driveelement 3302 to advance, thereby allowing control of the rotatable nut3304 to enable precise metering out of the liquid drug 1510. In variousembodiments, one rotation of the rotatable nut 3304 can correspond toadvancement of the flexible drive element by an amount corresponding toa thickness or width or the flexible drive element 3302 (e.g., adiameter of the flexible drive element 3302 when implemented as acircular or round spring).

FIG. 34 illustrates an exemplary alternative drive system 3400 fordelivering a liquid drug to a patient. The drive system 3400 can be usedwith any of the drug delivery devices described herein (e.g., the drugdelivery device 100). The drive system 3400 can be used to advance themovement of a plunger as desired to provide delivery of the liquid drugover multiple doses. The drive system 3400 can correspond to the drivemechanism 210 described in relation to FIGS. 2 and 3. The drive system3400 can include any feature of any of the other drive systems describedherein.

FIG. 34 illustrates the drive system 3400 in a first position oroperating state. As shown in FIG. 34, the drive system 3400 can includea drug container 3402 (e.g., corresponding to the primary drug container1502). The container 3402 can contain a liquid drug or medicine (e.g.,corresponding to the liquid drug 1510). The container 3402 can be aprefilled cartridge. A plunger 3404 (e.g., corresponding to the plunger1508) can initially be positioned in proximity to a first end of thecontainer 3402. A fluid exit path 3406 can be positioned in proximity toa second, opposite end of the container 3402. The fluid exit path 3406can include tubing, a needle, and/or a cannula for transferring a fluidfrom one location to another. The fluid exit path 3406 can be coupled tothe container 3402 and can be in fluid communication with the contentsof the container 3402. The fluid exit path 3406 can correspond to theneedle conduit 1514 or a portion thereof. As the plunger 3404 is moved(e.g., from the first end of the container 3402 to the second end of thecontainer 3402), the liquid drug inside of the container 3402 can beforced out of the container 3402 and through the fluid exit path 3406for delivery to a patient.

The plunger 3404 can be moved in a direction towards the second end ofthe container 3402 (towards the needle conduit 3406) by one or morespheres 3408 (e.g., corresponding to the spheres 1520). The spheres 3408can be positioned within and can travel within a sphere path 3410. Thepositioning of the spheres 3408 can be maintained by a wall stop 3412and an actuated stop 3414. Specifically, the wall stop 3412, theactuated stop 3414, and the sphere path 3410 can maintain one or morespheres adjacent to the plunger 3404.

The actuated stop 3414 can be moved by a drive system. The drive systemcan be an electromechanical drive system. The actuated stop 3414 canmove left and right (relative to the orientation shown in FIG. 34) toopen and close a space between the actuated stop 3414 and the plunger3404. As shown in FIG. 34, the actuated stop 3404 can be considered tobe in an open position such that one or more spheres 3408 can bepositioned between the actuated stop 3414 and the plunger 3404. Thecontainer 3402 can generally be cylindrical in shape but is not solimited and can have a diameter of D1 as indicated in FIG. 34. Thespheres 3408 can generally be spherical in shape but are not so limitedand can have a diameter of D2 as shown in FIG. 34. The diameter D2 ofthe spheres 3408 can be slightly smaller than the diameter D1 of thecontainer 3402.

The actuated stop 3414 can be moved by a mechanical, electrical, and/orelectromechanical drive system. As an example, the actuated stop 3414can be coupled to a linear induction motor that enables the actuatedstop 3414 to move forward and backwards. When the actuated stop 3414moves to the left, a space can open up between the actuated stop 3414and the plunger 3404. Depending on the size of the open space, one ormore spheres 3408 can move upwards from the sphere path 3410 to occupythe open space. As shown in FIG. 34, a single sphere 3408 is positionedadjacent to the wall stop 3412 and between the actuated stop 3414 andthe plunger 3404.

Once at least one sphere 3408 is positioned as shown in FIG. 34, theactuated stop 3414 can be moved to the right (towards the plunger 3404).Movement of the actuated top 3414 towards the plunger 3404 can cause thesphere 3048 to push against the plunger 3404. The force of the sphere3408 against the plunger 3404 can cause the plunger 3404 to move to theright (towards the needle conduit 3046). Movement of the plunger 3404towards the needle conduit 3406 can cause the liquid drug stored in thecontainer 3402 to be forced out of the container 3402 and into the fluidexit path 3406. Accordingly, the movement of the actuated stop 3414 cancause a portion of the liquid drug from the container 3402 to bedelivered to a patient.

The amount of drug delivered to the patient can be determined based onthe amount of movement of the actuated stop 3414 and/or the diameter D2of the spheres 3408. For example, a single dose of a drug can correspondto the amount of drug expelled from the container 3402 when the plunger3404 is moved by an amount corresponding to the diameter D2 of a singlesphere 3408. In various embodiments, the actuated stop 3414 can be movedto allow more than one sphere 3408 to push the plunger 3404 forwardduring each actuation of the actuated stop 3414. In various embodiments,the actuated stop 3414 can be moved to allow the plunger 3404 to move adistance that is less than a diameter of the sphere 3408. Accordingly,any size dosage can be provided by the drive system 3400 (e.g., anydosage corresponding to any distance the plunger moves 3404corresponding to any portion of the diameter of a sphere 3408 or morethan one sphere 3408). Further, as shown in 3418, a force 3418 can beprovided to positon the spheres 3408 towards the wall stop 3412. Theforce 3418 can be provided by any mechanical and/or electromechanicalmechanism such as, for example, a spring or motor.

FIG. 35 illustrates the drive system 3400 in a second position oroperating state. As shown in FIG. 35, the actuated stop 3414 has beenmoved to the right towards the plunger 3404. As a result, the firstsphere 3408 has been moved forward towards the plunger 3404 causing theplunger to move towards the fluid exit path 3406. The movement of theplunger 3404 by being pushed by the sphere 3408 causes a portion of theliquid drug of the container 3402 to be pushed out through the fluidexit path 3406.

As shown in FIG. 35, the plunger 3404 has been moved by a distanceapproximately equal to the diameter D2 of the sphere 3408. This amountof plunger 3404 movement can correspond to one dosage of the liquid drugstored in the container but is not so limited. Overall, the diameter D2of the spheres 3408 can set the dosage amount per sphere 3408 with theamount of dosage of the drug being equal to the number of sphere 3408diameters or fractions thereof which correspond to the amount of plunger3404 movement.

The drive system 3400 can be used to push the spheres 3408 and theplunger 3404 in a controlled manner. The speed at which these componentsare pushed can determine the speed of delivery of the drug and can beadjusted or varied. The operation of the drive system 3400 can togglebetween the two states shown in FIGS. 34 and 35. For example, in a nextoperating state of the drive system 3400, the actuated stop 3414 can bemoved back away from the plunger 3404 to open up a space for a nextsphere 3408. As a result, two spheres 3408 can be positioned adjacent toone another in line with the actuated stop 3414 and the plunger 3404. Anext amount of drug can be delivered to the patient when the actuatedstop 3414 moves forward again towards to the plunger 3404 to push bothspheres 3408 against the plunger 3404.

A sensor 3416 as shown in FIGS. 34 and 35 can be used to detect theposition of the actuated stop 3414 and/or the positions of the spheres3408. The sensor 3416 can provide an indication of positon of thesecomponents to a drive system and/or controller for moving the actuatedstop 3414. In various embodiments, the sensor 3416 can be a Hall effectsensor. The sensor 3416 can be coupled to a controller or other logicthat can maintain a count of how many spheres have been moved into thepositon to move the plunger 3404. In doing so, a measure of the numberand size of doses can be tracked. The wall stop 3412 can be fixed or canbe moveable. In various embodiments, the wall stop 3412 can be movedback and forth (e.g., up and down relative to the orientation shown inFIGS. 34 and 35) to enable spheres 3408 to be moved up near thecontainer 3402.

The drive system 3400 provides numerous benefits over conventional drugdelivery systems. First, the drive system 3400 provides a mechanism forstarting and stopping delivery of the drug contained in the container3402. As a result, the drive system 3400 can start and stop delivery ofthe drug and can therefore provide multiple doses of a drug over adesired period of time according to a delivery schedule. Further, thecompact design of the drive system 3400 enables the drive system 3400 tobe placed inside of a wearable drug delivery device that can remainsmall and compact in size. The drive system 3400 also enables actuationof the plunger 3404 on a sphere by sphere basis.

FIG. 36 illustrates a fifth exemplary embodiment of a drug deliverydevice 3600. The drug delivery device 3600 can operate and providesubstantially the same delivery device 3600 can include a top portion3602 and a bottom portion 3604. The top portion 3602 and the bottomfunctionality as the drug device 100, the drug delivery device 900, thedrug delivery device 1400, and/or the drug delivery device 2500. Asshown in FIG. 36, the drug portion 3604 can together form a housing ofthe drug delivery device 3600. The top portion 3602 and the bottomportion 3604 can be coupled together to form an outside of the drugdelivery device 3600. The drug delivery device 3600 can representanother design or form factor of the drug delivery device 100, the drugdelivery device 900, the drug delivery device 1400, and/or the drugdelivery device 2500.

As shown in FIG. 36, the drug delivery device 3600 includes an opening3606. The opening 3606 can be used for inserting or removing a drugcartridge (e.g., the primary drug container 1502). The opening 3606 canbe a hole or slot and can have a door (e.g., a hinged door) formaintaining the cartridge inside of the drug delivery device 3600. Inthis way, the drug delivery device 3600 can be loaded with prefilledcartridges and can be reused as it allows spent cartridges to removedand discarded.

FIG. 37 illustrates an exemplary embodiment of a needle insertionmechanism or component 3700. The needle insertion mechanism 3700 cancorrespond to the needle insertion mechanism 208 described in relationto FIGS. 2 and 3. The needle insertion mechanism 1516 can represent animplementation of the needle insertion mechanism 3700. The needleinsertion mechanism 3700 can be used with or be a part of any of thedrug delivery devices described herein.

As shown in FIG. 37, the needle insertion mechanism 3700 can include afirst component 3702 and a second component 3704. The first and secondcomponents 3702 and 3704 can be coupled to a track 3710. The first andsecond components 3702 and 3704 can be positioned on top of the track3710 and can slide back and forth along the track 3710.

The first and second components 3702 and 3704 can be coupled to a needleor tubing 3706. The needle 3706 can be a portion of the needle conduit206. The needle 3706 can be routed through the first and secondcomponents 3702 and 3704. A second needle or cannula 3708 can be coupledto the first component 3702. The second needle or cannula 3708 can alsobe a part of the needle conduit 206. The second needle or cannula 3708can be a soft needle or cannula and can be formed from a soft plasticmaterial.

As shown in FIG. 37, the needle 3706 can be positioned within thecannula 3708. Together, the needle 3706 and the cannula 3708 canrepresent or be referred to as a transcutaneous access component. Thetrack 3710 can be coupled to an interior portion of a bottom portion ofa drug delivery device (e.g., the lower portion 104 of the drug deliverydevice 100).

When the needle insertion mechanism 3700 is activated, the first andsecond components 3702 and 3704 can slide forward, driving the cannula3708 and the needle 3706 forward. When driven forward, the needle 3706can be inserted into the patient. The second component 3704 cansubsequently slide back, retracting the needle 3706. The first component3702 can remain slid forward, leaving the cannula 3708 inside of thepatient. The end of the needle 3706 that accesses the patient can be ahard or sharp portion of the needle 3706. When the needle 3706 isretracted, only the soft needle or cannula 3708 can remain inside of thepatient. The soft needle 3704 can be coupled to the hard needle 3706and/or the needle conduit 206, thereby providing a complete fluid pathfrom the primary drug container of a drug delivery device to thepatient.

The end of the cannula 3708 can correspond to the protrusion 502 and/orthe protrusion 1102. The end of the cannula 3708 can remain inside ofthe drug delivery device prior to activation. The hard needle 3706 canbe retracted back inside of the drug delivery device after providingaccess to the patient. The portion of the hard needle 3706 that extendsfrom the second component 3704 can be relatively softer than a portionof the needle 3706 extending from the first component 3702. In variousembodiments, the hard needle 3706 and the cannula 3708 can be part ofthe needle conduit 1514.

FIG. 38 illustrates an exemplary embodiment of a track or guide 3802.The track 3802 can represent an implementation of the track 1514. Thetrack 3802 can be used with any of the drug delivery systems or drivesystems described herein. FIG. 38 shows a cross-sectional view of thetrack 3802.

As shown in FIG. 38, the track 3802 can be circular. A sphere 3804 (alsoshown in cross-section) can be positioned inside of the track 3802. Thesphere 3804 can represent a sphere 1520.

The track 3802 can have an inner diameter that is slightly larger than adiameter of the sphere 3804, thereby allowing the sphere 3804 to movethrough the track 3804. A gap or distance 3806 shows a difference in thediameters of the track 3802 (e.g., inner diameter) and the sphere 3804.For purposes of illustration and explanation, the sphere 3804 is showncentered within the interior of the track 3802. During operation (e.g.,movement of the sphere 3804 within the track 3802), the sphere 3804 canmake contact with a portion of an inner surface of the track 3802.

The track 3802 can provide more efficient movement of the sphere 3804than a conventional square-shaped track (i.e., a track having a squarecross-sectional shape or profile). The track 3802 can enable the sphere3804 to move through the track with less friction force to overcome thana square shaped track. In turn, the efficiency of a drive system thatuses the track 3802 can be more efficient, as less force can be used toovercome frictional forces when moving the sphere 3804.

The track 3802 can be formed of any material including a plasticmaterial or a metal material (e.g., stainless steel). The track 3802 canbe formed from two or more pieces joined together at split pointrepresented by a split line. Split line 3808 can represent a midpoint ofa conventional track. The split line 3808 is positioned at anapproximate halfway point of the track 3802. That is, the split line3808 splits the track 3802 into two equal sections (e.g., an uppersection and a lower section). The split line 3810 can represent asecond, alternative split line of the track 3802 used in variousembodiments herein. The split line 3810 can split the track 3802 at anapproximately 60/40 split such that approximately 60% of the track 3802is positioned below the split line 3810 and approximately 40% of thetrack is positioned above the split line 3810. The split line 3810 canrepresent the positioning of where the upper and lower sections of thetrack 3802 are joined or put together to form the circular cross-sectionof the track 3802 as shown in FIG. 38.

Forming the track 3802 along the split line 3810 can improve theefficiency of the track 3802 compared to forming the track along thesplit line 3808. The split line 3808 can introduce relatively largerfrictional forces that may be required to be overcome when moving thesphere 3804 as compared to the relatively lower frictional forcesintroduced by forming the track 3802 along the split line 3810. As aresult, the efficiency of a drive system that uses the track 3802 havingthe track joined at the split line 3810 can be more efficient, as lessforce can be used to overcome frictional forces when moving the sphere3804.

The efficiency of the track 3802 (or a drive system using the track3802) can also be improved when the track 3802 is formed from relativelyharder materials. When the track 3802 is formed from relatively hardermaterials, the track 3802 may experience less deformation than whenformed of relatively softer materials. Accordingly, in variousembodiments, the track 3802 can be formed of relatively harder materialssuch as stainless steel or hard plastics to reduce deformation. Theefficiency of the track 3802 (or a drive system using the track 3802)can be improved by using spheres that are lubricious. Materials such asacetyl (e.g., Delrin) or similar plastics blended with a lubricant (suchas Teflon or PTFE) can be used to form the spheres and/or track 3802.

In various embodiments, the track 3802 can be formed from a single orunitary piece of material. The track 3802 can be formed from a plasticmaterial as a single element without joining two or more pieces at asplit line. For example, the track 3802 can be a plastic pipe or tubehaving a desired shape and curvature. In such embodiments, the track3802 can be formed and provided without a split line. In variousembodiments, the track 3802 can include one or more openings. Theopenings can accommodate portions of the drive systems for any of thedrug delivery devices described herein.

FIG. 41 illustrates an exemplary embodiment 4100 of an alternativerouting of the needle conduit 1514. The needle conduit 1514 depicted inFIG. 41 can be used with any of the drug delivery devices describedherein (e.g., the drug delivery device 100).

As shown in FIG. 41, the needle conduit 1514 can be coupled to a septum4102 of the primary drug container 1502. The needle conduit 1514 canprovide a fluid path from the septum 4102 of the primary drug container1502 to the needle insertion mechanism 1516. As shown in FIG. 41, thedrive spring 1518 can apply a force to the spheres 1520. The spheres1520 can transfer the force to the plunger 1508 to expel a liquid drugfrom the primary drug container 1502 through the septum 4102 and on tothe needle conduit 1514.

The needle conduit 1514 can be routed along any path relative to theother components depicted in FIG. 41. The routing of the needle conduit1514 as shown in FIG. 41 can be implemented or used with any of the drugdelivery devices and/or drive systems described herein.

Overall, any of the drug delivery devices described herein can use anytype of springs and any type of spring combinations for a drive spring.In general, the drive springs of the drug delivery devices describedherein, including any intermediate or interstitial springs or assistersprings, can be compression springs, torsion springs, or double-bodiedtorsion springs, or any combination thereof, and can be arranged inseries, parallel, or in a combination thereof. Any of the springsdescribed herein can be considered to be or referred to as drivesprings.

Any of the drug delivery devices described herein can include any of thedrive mechanisms described herein. Any of the drive mechanisms describedherein can be operated to provide a stored liquid drug to a patient in asingle dose or over multiple doses.

Each of the drug delivery devices and drive systems described herein caninclude or be implemented using a track—such as, for example the track1524 depicted in FIG. 15—to provide a pathway or guide for the spheres.In various illustrated embodiments the track has been omitted forsimplicity only. Each of the drug delivery devices and drive systemsdescribed herein can expel a stored liquid drug through the plungersealing a first end of drug cartridge or through a septum sealing asecond end of the drug cartridge as described herein. Accordingly, invarious embodiments, the needle conduit can be coupled to and/or canpierce the plunger of the drug cartridge or the septum of the drugcartridge. In various embodiments providing a fluid path through theneedle conduit positioned through the plunger, a primary drug containeraccess mechanism or component can be used as described herein (e.g.,positioned between the plunger and the drive mechanism or component). Invarious embodiments illustrating the needle conduit positioned throughthe plunger the primary drug container access mechanism may be omittedfor purposes of illustration and simplicity only.

The following examples pertain to further embodiments:

Example 1 is a drug delivery device, comprising a drug container forstoring a liquid drug, a first end of the drug container sealed by aplunger, a needle conduit coupled to the plunger, a needle insertioncomponent coupled to the needle conduit, and a drive component coupledto the plunger, the drive component comprising a drive spring and one ormore spheres.

Example 2 is an extension of Example 1 or any other example disclosedherein, wherein the plunger is movable toward a second end of the drugcontainer by operation of the drive component to expel the liquid drugout of the drug container through the needle conduit.

Example 3 is an extension of Example 2 or any other example disclosedherein, wherein the needle conduit is arranged to enable the liquid drugto be expelled from the drug container in a direction opposite to adirection of a movement of the plunger.

Example 4 is an extension of Example 1 or any other example disclosedherein, wherein the drive spring is directly coupled to at least one ofthe one or more spheres.

Example 5 is an extension of Example 4 or any other example disclosedherein, wherein the drive spring comprises two or more compressionsprings.

Example 6 is an extension of Example 5 or any other example disclosedherein, wherein the two or more compression springs are arranged inseries.

Example 7 is an extension of Example 6 or any other example disclosedherein, wherein the one or more spheres comprises a plurality ofspheres, and at least one of the two or more compression springs ispositioned between two adjacent spheres of the plurality of spheres.

Example 8 is an extension of Example 5 or any other example disclosedherein, wherein the two or more compression springs are arranged inparallel.

Example 9 is an extension of Example 1 or any other example disclosedherein, wherein the needle insertion component comprises a soft needleand a hard needle.

Example 10 is an extension of Example 9 or any other example disclosedherein, wherein the needle conduit is coupled to the soft needle.

Example 11 is an extension of Example 1 or any other example disclosedherein, wherein the needle conduit is directly coupled to the plunger.

Example 12 is an extension of Example 1 or any other example disclosedherein, further comprising a track providing a pathway for the one ormore spheres.

Example 13 is an extension of Example 12 or any other example disclosedherein, wherein the track comprises a circular cross-sectional shape.

Example 14 is an extension of Example 13 or any other example disclosedherein, wherein the drive spring and the one or more spheres arepositioned inside of the track.

Example 15 is an extension of Example 14 or any other example disclosedherein, wherein the track comprises stainless steel.

Example 16 is an extension of Example 1 or any other example disclosedherein, further comprising a drug container access component positionedbetween the plunger and a first sphere of the one or more spheres of thedrive component.

Example 17 is an extension of Example 16 or any other example disclosedherein, wherein the drug container access component maintains an end ofthe needle conduit within the plunger when the drug delivery device isin an idle state.

Example 18 is an extension of Example 17 or any other example disclosedherein, wherein the drug container access component is configured todrive the end of the needle conduit through the plunger to couple theend of the needle conduit to the liquid drug when the drug deliverydevice is in an activated state.

Example 19 is an extension of Example 18 or any other example disclosedherein, wherein the drug container access component further comprises aneedle pilot component positioned adjacent to the plunger, a pusherplate component positioned adjacent to the first sphere, and a spacerspring positioned between the needle pilot component and the pusherplate component.

Example 20 is an extension of Example 19 or any other example disclosedherein, wherein the spacer spring is configured to be in an expandedconfiguration when the drug delivery device is in the idle state tothereby maintain a space between the needle pilot component and thepusher plate component.

Example 21 is an extension of Example 20 or any other example disclosedherein, wherein the spacer spring is configured to be in a compressedconfiguration when the drug delivery device is in the activated state.

Example 22 is an extension of Example 21 or any other example disclosedherein, wherein when the drug delivery device is in the activated state,the first sphere applies a force on the pusher plate component tocompress the spacer spring against the needle pilot component.

Example 23 is an extension of Example 22 or any other example disclosedherein, wherein the force applied by the first sphere drives the end ofthe needle conduit through the plunger by driving the needle pilotcomponent toward the plunger.

Example 24 is an extension of Example 1 or any other example disclosedherein, wherein the drug container comprises an InternationalOrganization for Standardization (ISO) standardized cartridge.

Example 25 a method for delivering a liquid drug stored in a drugcontainer of a drug delivery device to a patient, comprising activatingthe drug delivery device, accessing the patient with a needle insertioncomponent of the drug delivery device, accessing the liquid drug in thedrug container with a needle conduit extending through a plunger sealinga first end of the drug container, and driving the plunger toward asecond end of the drug container to expel the liquid drug through theneedle conduit for delivery to the patient through the needle insertioncomponent.

Example 26 is an extension of Example 25 or any other example disclosedherein, wherein activating comprises receiving a patient input.

Example 27 is an extension of Example 25 or any other example disclosedherein, wherein accessing the patient comprises piercing the patientwith a hard needle and a soft needle, retracting the hard needle, andmaintaining the soft needle in the patient.

Example 28 is an extension of Example 25 or any other example disclosedherein, wherein accessing the liquid drug comprises piercing the plungerwith an end of the needle conduit to couple the needle conduit to theliquid drug.

Example 29 is an extension of Example 25 or any other example disclosedherein, wherein driving the plunger comprises providing a force usingone or more compression drive springs and applying the force to theplunger using one or more spheres.

Example 30 is an extension of Example 25 or any other example disclosedherein, further comprising expelling the liquid drug from the drugcontainer through the first end of the drug container.

Example 31 is a drug delivery device, comprising a drug container forstoring a liquid drug, a first end of the drug container sealed by aseptum and second end of the plunger sealed by a plunger, a needleconduit coupled to the liquid drug, a needle insertion component coupledto the needle conduit, and a drive component coupled to the plunger, thedrive component comprising one or more spheres.

Example 32 is an extension of Example 31 or any other example disclosedherein, wherein the drug container comprises an InternationalOrganization for Standardization (ISO) standardized cartridge.

Example 33 is an extension of Example 31 or any other example disclosedherein, wherein the plunger is movable toward a first end of the drugcontainer by operation of the drive component to expel the liquid drugout of the drug container through the needle conduit.

Example 34 is an extension of Example 33 or any other example disclosedherein, wherein the needle conduit is coupled to the liquid drug throughthe septum.

Example 35 is an extension of Example 34 or any other example disclosedherein, wherein the needle conduit is arranged to enable the liquid drugto be expelled from the drug container in a direction corresponding to adirection of a movement of the plunger.

Example 36 is an extension of Example 33 or any other example disclosedherein, wherein the needle conduit is coupled to the liquid drug throughthe plunger.

Example 37 is an extension of Example 36 or any other example disclosedherein, wherein the needle conduit is arranged to enable the liquid drugto be expelled from the drug container in a direction opposite to adirection of a movement of the plunger.

Example 38 is an extension of Example 31 or any other example disclosedherein, wherein the one or more spheres comprises a plurality ofspheres, wherein the drive component comprises two or more compressionssprings, and at least one of the two or more compression springs ispositioned between two adjacent spheres of the plurality of spheres.

Example 39 is an extension of Example 31 or any other example disclosedherein, wherein the drive component further comprises a drive spring.

Example 40 is an extension of Example 39 or any other example disclosedherein, wherein the drive spring is coupled to a sphere of the one ormore spheres positioned furthest from the plunger.

Example 41 is an extension of Example 40 or any other example disclosedherein, wherein the drive spring comprises two or more compressionsprings.

Example 42 is an extension of Example 41 or any other example disclosedherein, wherein the two or more compression springs are arranged inseries.

Example 43 is an extension of Example 41 or any other example disclosedherein, wherein the two or more compression springs are arranged inparallel.

Example 44 is an extension of Example 39 or any other example disclosedherein, further comprising a track providing a pathway for the spheres.

Example 45 is an extension of Example 44 or any other example disclosedherein, the track having a circular cross-sectional shape.

Example 46 is an extension of Example 45 or any other example disclosedherein, wherein the drive spring and the one or more spheres arepositioned inside of the track.

Example 47 is an extension of Example 31 or any other example disclosedherein, the drive component further comprising a torsion spring.

Example 48 is an extension of Example 47 or any other example disclosedherein, the torsion spring comprising a double-bodied torsion spring.

Example 49 is an extension of Example 48 or any other example disclosedherein, wherein an arm of the double-bodied torsion spring is coupled toa sphere of the one or more spheres positioned furthest away from theplunger.

Example 50 is an extension of Example 49 or any other example disclosedherein, further comprising a track for containing the spheres.

Example 51 is an extension of Example 50 or any other example disclosedherein, wherein the track comprises a circular cross-sectional shape.

Example 52 is an extension of Example 51 or any other example disclosedherein, wherein the track comprising an opening positioned adjacent tothe double-bodied torsion spring to allow the arm to rotate within thetrack.

Example 53 is an extension of Example 31 or any other example disclosedherein, the drive component further comprising two or more torsionsprings.

Example 54 is an extension of Example 53 or any other example disclosedherein, the two or more torsion springs arranged in series.

Example 55 is an extension of Example 53 or any other example disclosedherein, the two or more torsion springs arranged in parallel.

Example 56 is a method for delivering a liquid drug stored in a drugcontainer of a drug delivery device to a patient, comprising activatingthe drug delivery device, accessing the patient with a needle insertioncomponent of the drug delivery device, accessing the liquid drug in thedrug container with a needle conduit, and driving a plunger sealing afirst end of the drug container toward a second end of the drugcontainer to expel the liquid drug through the needle conduit fordelivery to the patient through the needle insertion component.

Example 57 is an extension of Example 56 or any other example disclosedherein, wherein activating comprises receiving a patient input.

Example 58 is an extension of Example 56 or any other example disclosedherein, wherein accessing the liquid drug comprises piercing the plungerwith an end of the needle conduit to couple the needle conduit to theliquid drug.

Example 59 is an extension of Example 58 or any other example disclosedherein, wherein piercing the plunger comprising applying a force to aneedle pilot component coupled to the plunger to drive the needle pilotcomponent toward the plunger, the needle pilot component housing theneedle conduit.

Example 60 is an extension of Example 59 or any other example disclosedherein, further comprising compressing a spacer spring coupled to theneedle pilot component to apply the force to the needle pilot component.

Example 61 is an extension of Example 60 or any other example disclosedherein, further comprising compressing the spacer spring by driving apusher plate coupled to the spacer spring toward the spacer spring.

Example 62 is an extension of Example 56 or any other example disclosedherein, wherein accessing the liquid drug comprises piercing a septumsealing the second end of the drug container with the needle conduit tocouple the needle conduit to the liquid drug.

Example 63 is an extension of Example 56 or any other example disclosedherein, wherein driving the plunger comprises providing a force usingone or more compression drive springs and applying the force to theplunger through one or more spheres.

Example 64 is an extension of Example 56 or any other example disclosedherein, wherein driving the plunger comprises providing a force using atorsion spring and applying the force to the plunger through one or morespheres.

The following additional examples pertain to further embodiments:

Example 1 is a drug delivery device configured to deliver a liquid drugto a patient over two or more doses, comprising a drug containerconfigured to store the liquid drug, a first end of the drug containersealed by a plunger, a needle conduit coupled to the plunger, a needleinsertion component coupled to the needle conduit, and a drive componentcoupled to the plunger, the drive component comprising a dosing wheeland a plurality of spheres.

Example 2 is an extension of Example 1 or any other example disclosedherein, wherein the dosing wheel comprises a hub and a plurality ofradially extending arms.

Example 3 is an extension of Example 2 or any other example disclosedherein, wherein one or more of the plurality of radially extending armsare positioned between adjacent spheres of the plurality of spheres.

Example 4 is an extension of Example 3 or any other example disclosedherein, wherein a rotation of the dosing wheel in a first directionadvances the plurality of spheres toward the plunger.

Example 5 is an extension of Example 4 or any other example disclosedherein, wherein the plurality of spheres are configured to apply a forceto the plunger to move the plunger toward a second end of the drugcontainer to expel the liquid drug out of the drug container through theneedle conduit.

Example 6 is an extension of Example 5 or any other example disclosedherein, wherein a predetermined amount of the rotation of the dosingwheel causes a predetermined amount of the liquid drug expelled from thedrug container.

Example 7 is an extension of Example 5 or any other example disclosedherein, wherein the dosing wheel is configured such that stopping therotation of the dosing wheel stops the liquid drug from being expelledfrom the drug container and restarting the rotation of the dosing wheelrestarts the liquid drug being expelled from the drug container.

Example 8 is an extension of Example 4 or any other example disclosedherein, wherein the rotation of the dosing wheel is controllable by userinput.

Example 9 is an extension of Example 4 or any other example disclosedherein, further comprising a controller, wherein the rotation of thedosing wheel is controllable by the controller.

Example 10 is an extension of Example 4 or any other example disclosedherein, wherein the drive component further comprises one or morecompression springs.

Example 11 is an extension of Example 10 or any other example disclosedherein, wherein the one or more compressions springs are configured toapply a force to the plurality of spheres to move the plunger toward thesecond end of the drug container.

Example 12 is an extension of Example 5 or any other example disclosedherein, wherein the needle conduit is arranged to enable the liquid drugto be expelled from the drug container in a direction opposite to adirection of a movement of the plunger.

Example 13 is an extension of Example 1 or any other example disclosedherein, wherein the drug container comprises an InternationalOrganization for Standardization (ISO) standardized cartridge.

Example 14 is an extension of Example 1 or any other example disclosedherein, wherein the needle insertion component comprises a soft needleand a hard needle.

Example 15 is an extension of Example 14 or any other example disclosedherein, wherein the needle conduit is coupled to the soft needle.

Example 16 a method for delivering a liquid drug stored in a drugcontainer of a drug delivery device to a user over two or more doses,comprising activating the drug delivery device, accessing the user witha needle component of the drug delivery device, coupling the liquid drugto a needle conduit, the needle conduit coupled to the needle component,driving a plurality of spheres toward a plunger sealing a first end ofthe drug container, and rotating a dosing wheel having one or moreradially extending arms positioned between one or more spheres of theplurality of spheres to regulate a movement of the plurality of spherestoward the plunger to expel the liquid drug through the needle conduitfor delivery to the user.

Example 17 is an extension of Example 16 or any other example disclosedherein, wherein rotating the dosing wheel comprises regulating themovement of the plurality of spheres toward a second end of the drugcontainer.

Example 18 is an extension of Example 16 or any other example disclosedherein, further comprising coupling the liquid drug to the needleconduit through the plunger.

Example 19 is an extension of Example 16 or any other example disclosedherein, wherein driving further comprises driving the plurality ofspheres with one or more compression drive springs.

Example 20 is an extension of Example 16 or any other example disclosedherein, wherein activating further comprises receiving a user input.

Example 21 is a drug delivery device for delivering a liquid drug to apatient over two or more doses, comprising a drug container for storinga liquid drug, a first end of the drug container sealed by a septum andsecond end of the plunger sealed by a plunger, a needle conduit coupledto the liquid drug, a needle insertion component coupled to the needleconduit, and a drive component coupled to the plunger, the drivecomponent comprising one or more spheres and a rotatable arm.

Example 22 is an extension of Example 21 or any other example disclosedherein, wherein the one or more spheres are coupled to the plunger.

Example 23 is an extension of Example 22 or any other example disclosedherein, wherein the rotatable arm is coupled to a first sphere of theone or more spheres positioned furthest from the plunger.

Example 24 is an extension of Example 23 or any other example disclosedherein, wherein the plunger is movable toward the first end of the drugcontainer by rotation of the rotatable arm to expel the liquid drug outof the drug container through the needle conduit.

Example 25 is an extension of Example 24 or any other example disclosedherein, wherein the needle conduit is arranged to enable the liquid drugto be expelled from the drug container in a direction opposite to adirection of a movement of the plunger.

Example 26 is an extension of Example 24 or any other example disclosedherein, wherein the needle conduit is arranged to enable the liquid drugto be expelled from the drug container in a direction corresponding to adirection of a movement of the plunger.

Example 27 is an extension of Example 24 or any other example disclosedherein, wherein a predetermined amount of the rotation of the rotatablearm causes a predetermined amount of the liquid drug to expel from thedrug container.

Example 28 is an extension of Example 27 or any other example disclosedherein, wherein the rotatable arm is configured such that stopping therotation of the rotatable arm stops the liquid drug from being expelledfrom the drug container and restarting the rotation of the rotatable armrestarts the liquid drug being expelled from the drug container.

Example 29 is an extension of Example 24 or any other example disclosedherein, wherein the rotation of the rotatable arm is controllable byuser input.

Example 30 is an extension of Example 24 or any other example disclosedherein, further comprising a controller, wherein the rotation of therotatable arm is controllable by the controller.

Example 31 is an extension of Example 21 or any other example disclosedherein, wherein the rotatable arm comprises an arm of a torsion spring.

Example 32 is a method for delivering a liquid drug stored in a drugcontainer of a drug delivery device to a user over two or more doses,comprising activating the drug delivery device, accessing the user witha needle component of the drug delivery device, coupling the liquid drugto a needle conduit, the needle conduit coupled to the needle component,driving a plurality of spheres toward a plunger sealing a first end ofthe drug container, and rotating a rotatable arm coupled to theplurality of spheres to regulate a movement of the plurality of spherestoward the plunger to expel the liquid drug through the needle conduitfor delivery to the user.

Example 33 is an extension of Example 32 or any other example disclosedherein, further comprising rotating the rotatable arm a predeterminedamount to cause a predetermined amount of the liquid drug to expel fromthe drug container.

Example 34 is a drug delivery device for delivering a liquid drug to apatient over two or more doses, comprising a drug container for storinga liquid drug, a first end of the drug container sealed by a septum andsecond end of the plunger sealed by a plunger, a needle conduit coupledto the liquid drug, a needle insertion component coupled to the needleconduit, and a drive component coupled to the plunger, the drivecomponent comprising a flexible drive component and a rotatable nut.

Example 35 is an extension of Example 34 or any other example disclosedherein, wherein the rotatable nut is coupled to the second end of thedrug container.

Example 36 is an extension of Example 35 or any other example disclosedherein, wherein the flexible drive component is coupled to the plungerthrough the rotatable nut.

Example 37 is an extension of Example 36 or any other example disclosedherein, wherein the plunger is movable toward the first end of the drugcontainer by rotation of the rotatable nut to expel the liquid drug outof the drug container through the needle conduit.

Example 38 is an extension of Example 37 or any other example disclosedherein, wherein the rotation of the rotatable nut is configured to drivethe flexible drive component towards the plunger to apply a force to theplunger to move the plunger toward the first end of the drug container.

Example 39 is an extension of Example 37 or any other example disclosedherein, wherein the needle conduit is arranged to enable the liquid drugto be expelled from the drug container in a direction opposite to adirection of a movement of the plunger.

Example 40 is an extension of Example 37 or any other example disclosedherein, wherein the needle conduit is arranged to enable the liquid drugto be expelled from the drug container in a direction corresponding to adirection of a movement of the plunger.

Example 41 is an extension of Example 37 or any other example disclosedherein, wherein a predetermined amount of the rotation of the rotatablenut causes a predetermined amount of the liquid drug to expel from thedrug container.

Example 42 is an extension of Example 41 or any other example disclosedherein, wherein the rotatable nut is configured such that stopping therotation of the rotatable nut stops the liquid drug from being expelledfrom the drug container and restarting the rotation of the rotatable nutrestarts the liquid drug being expelled from the drug container.

Example 43 is an extension of Example 36 or any other example disclosedherein, wherein the rotation of the rotatable nut is controllable byuser input.

Example 44 is an extension of Example 36 or any other example disclosedherein, further comprising a controller, wherein the rotation of therotatable arm is controllable by the controller.

Example 45 is an extension of Example 34 or any other example disclosedherein, wherein the flexible drive component comprises a compressionspring.

Example 46 is a method for delivering a liquid drug stored in a drugcontainer of a drug delivery device to a user over two or more doses,comprising activating the drug delivery device, accessing the user witha needle component of the drug delivery device, coupling the liquid drugto a needle conduit, the needle conduit coupled to the needle component,coupling a rotatable component to a flexible component, the rotatablecomponent coupled to a first end of the drug container sealed by aplunger, coupling the flexible component to the plunger through therotatable component, and rotating the rotatable component to drive theflexible component toward the plunger to move the plunger toward asecond end of the drug container to expel the liquid drug through theneedle conduit for delivery to the user.

Example 46 is an extension of Example 46 or any other example disclosedherein, further comprising rotating the rotatable component apredetermined amount to cause a predetermined amount of the liquid drugto expel from the drug container.

Certain embodiments of the present invention were described above. Itis, however, expressly noted that the present invention is not limitedto those embodiments, but rather the intention is that additions andmodifications to what was expressly described herein are also includedwithin the scope of the invention. Moreover, it is to be understood thatthe features of the various embodiments described herein were notmutually exclusive and can exist in various combinations andpermutations, even if such combinations or permutations were not madeexpress herein, without departing from the spirit and scope of theinvention. In fact, variations, modifications, and other implementationsof what was described herein will occur to those of ordinary skill inthe art without departing from the spirit and the scope of theinvention. As such, the invention is not to be defined only by thepreceding illustrative description.

1. A drug delivery device for delivering a liquid drug to a patient overtwo or more doses, comprising: a drug container configured to store theliquid drug, a first end of the drug container sealed by a plunger; aneedle conduit coupled to the plunger; a needle insertion componentcoupled to the needle conduit; and a drive component coupled to theplunger, the drive component comprising a dosing wheel and a pluralityof spheres.
 2. The drug delivery device of claim 1, wherein the dosingwheel comprises a hub and a plurality of radially extending arms.
 3. Thedrug delivery device of claim 2, wherein one or more of the plurality ofradially extending arms are positioned between adjacent spheres of theplurality of spheres.
 4. The drug delivery device of claim 3, wherein arotation of the dosing wheel in a first direction advances the pluralityof spheres toward the plunger.
 5. The drug delivery device of claim 4,wherein the plurality of spheres are configured to apply a force to theplunger to move the plunger toward a second end of the drug container toexpel the liquid drug out of the drug container through the needleconduit.
 6. The drug delivery device of claim 5, wherein a predeterminedamount of the rotation of the dosing wheel causes a predetermined amountof the liquid drug to expel from the drug container.
 7. The drugdelivery device of claim 6, wherein the dosing wheel is configured suchthat stopping the rotation of the dosing wheel stops the liquid drugfrom being expelled from the drug container and restarting the rotationof the dosing wheel restarts the liquid drug being expelled from thedrug container.
 8. The drug delivery device of claim 4, wherein therotation of the dosing wheel is controllable by user input.
 9. The drugdelivery device of claim 4, further comprising a controller, wherein therotation of the dosing wheel is controllable by the controller.
 10. Thedrug delivery device of claim 4, wherein the drive component furthercomprises one or more compression springs.
 11. The drug delivery deviceof claim 10, wherein the one or more compressions springs are configuredto apply a force to the plurality of spheres to move the plunger towardthe second end of the drug container.
 12. The drug delivery device ofclaim 5, wherein the needle conduit is arranged to enable the liquiddrug to be expelled from the drug container in a direction opposite to adirection of a movement of the plunger.
 13. The drug delivery device ofclaim 1, wherein the drug container comprises an InternationalOrganization for Standardization (ISO) standardized cartridge.
 14. Thedrug delivery device of claim 1, wherein the needle insertion componentcomprises a soft needle and a hard needle.
 15. The drug delivery deviceof claim 14, wherein the needle conduit is coupled to the soft needle.16. A method for delivering a liquid drug stored in a drug container ofa drug delivery device to a user over two or more doses, comprising:activating the drug delivery device; accessing the user with a needlecomponent of the drug delivery device; coupling the liquid drug to aneedle conduit, the needle conduit coupled to the needle component;driving a plurality of spheres toward a plunger sealing a first end ofthe drug container; and rotating a dosing wheel having one or moreradially extending arms positioned between one or more spheres of theplurality of spheres to regulate a movement of the plurality of spherestoward the plunger to expel the liquid drug through the needle conduitfor delivery to the user.
 17. The method of claim 16, wherein rotatingthe dosing wheel comprises regulating the movement of the plurality ofspheres toward a second end of the drug container.
 18. The method ofclaim 16, further comprising coupling the liquid drug to the needleconduit through the plunger.
 19. The method of claim 16, wherein drivingfurther comprises driving the plurality of spheres with one or morecompression drive springs.
 20. The method of claim 16, whereinactivating further comprises receiving a user input.